Skin structures and soft tissue infections

SHIRLEY, N.Y., Oct. 29, 2024 /PRNewswire/ -- American Regent announces the launch of 30 mL Epinephrine Injection, USP.1 Epinephrine Injection, USP is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Epinephrine is also indicated to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. Continue Reading Epinephrine Injection, USP is supplied as a 30 mg/30 mL (1 mg/mL) multiple-dose vial in a shelf pack of one. "With the approval of Epinephrine Injection, USP we continue to show our commitment to ensuring both patients and providers have access to high-quality treatment options," stated Joann Gioia, Vice President and Chief Commercial Officer at American Regent, Inc. Product is available for immediate shipment. Customers can order Epinephrine Injection, USP through their wholesaler/distributor or by contacting our Customer Support Group at 1-800-645-1706. Epinephrine Injection, USP is supplied as follows: Please see the accompanying Important Safety Information in addition to the Full Prescribing Information. For additional information, please visit americanregent.com. REFERENCE: 1. Epinephrine Injection, USP. Package insert. American Regent, Inc. © 2024 American Regent, Inc. All rights reserved. PP-EP-US-0024 5 Ramsey Road, Shirley, NY 11747 \\ 1.800.645.1706 F 631.924.1731 \\ A Daiichi Sankyo Group Company Epinephrine Injection, USP 30 mL For intramuscular, subcutaneous, and intravenous use. INDICATIONS AND USAGE Anaphylaxis Emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings or bites, foods, drugs, sera, diagnostic testing substances, and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. Hypotension associated with Septic Shock To increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS Incorrect Locations of Injection for Anaphylaxis: Injection into the anterolateral aspect of the thigh (vastus lateralis muscle) is the most appropriate location for administration because of its location, size, and available blood flow. Injection into (or near) smaller muscles, such as in the deltoid, is not recommended. Do not administer repeated injections of epinephrine at the same site, as the resulting vasoconstriction may cause tissue necrosis. Do not inject into buttock, digits, hands, or feet. Serious Infections at the Injection Site: Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported. Extravasation and Tissue Necrosis with Intravenous Infusion: Avoid extravasation into tissues, which can cause local necrosis. When epinephrine is administered intravenously, check the infusion site frequently. Hypertension: Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid excessive increases in blood pressure. Patients receiving monoamine oxidase inhibitors or antidepressants of the triptyline or imipramine types may experience severe, prolonged hypertension. Pulmonary Edema: Epinephrine increases cardiac output and causes peripheral vasoconstriction, which may result in pulmonary edema. Renal Impairment: Epinephrine constricts renal blood vessels, which may result in oliguria or renal impairment. Cardiac Arrhythmias and Ischemia: Epinephrine may induce cardiac arrhythmias and myocardial ischemia, especially in patients suffering from coronary artery disease or cardiomyopathy. May aggravate angina pectoris or produce ventricular arrhythmias. Allergic Reactions Associated with Sulfite: The Epinephrine 30 mL multiple-dose vial contains sodium metabisulfite, which may cause mild to severe allergic reactions including anaphylaxis or asthmatic episodes in susceptible individuals. ADVERSE REACTIONS Common adverse reactions to systemically administered epinephrine include, but are not limited to, anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with heart disease, hypertension, or hyperthyroidism. The true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below by body system: Cardiovascular: Angina, arrhythmias, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy. Rapid rises in blood pressure associated with epinephrine use have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Neurological: Disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling. Psychiatric: Anxiety, apprehensiveness, restlessness. Other: Patients with Parkinson's disease may experience psychomotor agitation or a temporary worsening of symptoms. Diabetic patients may experience transient increases in blood sugar. Injection into the buttock has resulted in cases of gas gangrene. Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh. USE IN SPECIFIC POPULATIONS Elderly patients and pregnant women may be at greater risk of developing adverse reactions when epinephrine is administered parenterally. Pregnancy May cause fetal harm. Labor or Delivery: There are risks to the mother and fetus associated with epinephrine use during labor or delivery. Epinephrine usually inhibits spontaneous or oxytocin-induced contractions of the pregnant human uterus and may delay the second stage of labor. Avoid epinephrine during the second stage of labor. Although epinephrine may improve maternal hypotension associated with septic shock and anaphylaxis, it may result in uterine vasoconstriction, decreased uterine blood flow, and fetal anoxia. Lactation There is no information regarding the presence of epinephrine in human milk or the effects of epinephrine on the breastfed infant or on milk production. Pediatric Use Reported clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Safety and effectiveness of epinephrine in pediatric patients with septic shock have not been established. Geriatric Use In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. OVERDOSAGE Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema, transient bradycardia followed by tachycardia, and these may be accompanied by potentially fatal cardiac arrhythmias. Subsidence of the ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Myocardial ischemia and infarction, cardiomyopathy, extreme pallor and coldness of the skin, metabolic acidosis due to elevated blood lactic acid levels, and renal insufficiency have also been reported. For additional Safety Information, please see the Full Prescribing Information. REF-2454 4/2023 You are encouraged to report adverse drug events (ADEs) to American Regent®: T 1.800.734.9236; E [email protected]; F 1.610.650.0170 ADEs may also be reported to the FDA: 1.800.FDA.1088 or Medical information: T 1.888.354.4855 (9:00 am–5:00 pm Eastern Time, Monday–Friday) medical information outside of normal business hours that cannot wait until the next business day, please call 1.877.845.6371 About American Regent For more than 50 years, American Regent has been developing, manufacturing, and supplying quality generic and branded injectables. For more than 20 years, we have been a leader in IV iron therapy. We are committed to setting a higher standard for responsiveness and reliability as a US-based manufacturer. To ensure that we deliver on our mission to improve human and animal health, we continue to make investments in expanding and modernizing our manufacturing facilities in Ohio and New York and have expanded our footprint into California. This growth will increase our capacity, create redundancies across our manufacturing sites, and strengthen our expertise in the development of complex drug products and delivery systems. What that means for you is a partner committed to delivering essential medications now and in the future. For more information, please visit . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical needs. For more information, please visit . SOURCE American Regent, Inc. 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Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). "This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata," said Brett King, MD, PhD. "These data highlight an important role for deuruxolitinib in the care of patients living with this disease." In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option. "As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option." LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com. About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New data demonstrate improved hair satisfaction in more than 95% of patients taking deuruxolitinib and clinically meaningful improvements in depression and anxiety from baseline to Week 24 Studies also confirm dose optimization, with results demonstrating greater response with 8 mg tablets twice-daily as compared to higher once-daily dosing MUMBAI, India and PRINCETON, N.J., Sept. 26, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced that it will present abstracts across its dermatology portfolio at the 33rd European Academy of Dermatology and Venereology (EADV) Congress being held in Amsterdam, Netherlands from September 25-28, 2024. Three abstracts, accepted for podium and poster presentation, will highlight clinical efficacy and safety data of LEQSELVI™ (deuruxolitinib) 8 mg tablets, an oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2 approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA). Notably, data presented in the podium presentation (FC04.04) found a greater proportion (95%) of patients taking deuruxolitinib 8 mg twice a day showed improvement in their hair satisfaction scores, compared to baseline over the 24-week period. Satisfaction with hair regrowth is imperative, as a significant number of patients with AA experience depression and anxiety due to the visible nature of the disease.1 The company will also share results in two additional posters for deuruxolitinib, which showed clinically meaningful improvement in anxiety and depression among patients taking deuruxolitinib to treat their severe AA (P2022) as well as dose optimization for deuruxolitinib at 8 mg (P2081). "Deuruxolitinib targets the immune mechanisms behind alopecia areata, providing patients with an effective treatment option," said Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair, Clinical Trials and Innovation and Director, Inpatient Dermatology, Brigham and Women's Hospital. "As a dermatologist, I find these data particularly encouraging because it addresses the physical effects of hair loss, which can, in turn, address the significant emotional and mental health challenges that patients often face." Additionally, 12 poster presentations will underscore the clinical efficacy and safety of ILUMYA® (tildrakizumab) in moderate-to-severe plaque psoriasis. These data also include research from interim data analysis from real-world settings. The following abstracts representing the dermatology portfolio will be presented at the 33rd EADV Congress: Deuruxolitinib Podium Presentation [FC04.04]: Change in patient-reported hair satisfaction during deuruxolitinib treatment of severe alopecia areata: Pooled data from the Phase 3 THRIVE-AA1 and THRIVE-AA2 trials (Presentation Time: September 26 at 16:30-16:40) Poster Presentation [P2022]: Improvement in anxiety and depression in adult patients with severe alopecia areata treated with deuruxolitinib: Pooled data from the THRIVE-AA1 and THRIVE-AA2 Phase 3 trials Poster Presentation [P2081]: Optimization of deuruxolitinib dosing in adult patients with alopecia areata: Results from a randomized, parallel-group, multicenter, Phase 2 trial Tildrakizumab Poster Presentation [P3221]: Comparative Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis: Systematic Literature Review (SLR) and Network Meta-Analysis (NMA) Poster Presentation [P3177]: Efficacy and safety of tildrakizumab through Week 28 in patients with early vs late-onset moderate-to-severe plaque psoriasis: A post hoc analysis of reSURFACE 1 and reSURFACE 2 Poster Presentation [P3274]: Improving the well-being of patients with moderate to severe plaque psoriasis and involvement of impactful areas with Tildrakizumab* Poster Presentation [P3348]: Effectiveness and Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA) of tildrakizumab patients with nail psoriasis: 52-week results from the phase IV POSITIVE Austrian subset* Poster Presentation [P3343]: Effectiveness of tildrakizumab in patients with moderate-to-severe psoriasis located in special areas: 52-week results from the POSITIVE study* Poster Presentation [P3341]: High effectiveness of tildrakizumab in bio-naïve and bio-experienced patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study* Poster Presentation [P3340]: High effectiveness of tildrakizumab regardless of baseline characteristics in patients with moderate-to-severe psoriasis: 52-week results from the POSITIVE study* Poster Presentation [P3188]: Patient-reported well-being using tildrakizumab for psoriasis in a real-world setting: 52-week interim data of the phase IV POSITIVE study* Poster Presentation [P3339]: Safety of tildrakizumab in patients with moderate-to-severe psoriasis: 52-week data from the phase IV POSITIVE study* Poster Presentation [P3346]: Effectiveness of tildrakizumab for itch, pain, and fatigue in patients with moderate-to-severe psoriasis: 52-week results from the real-world POSITIVE study* Poster Presentation [P3347]: Quality of life, work productivity and treatment satisfaction with tildrakizumab in moderate-to-severe psoriasis patients: 52-week interim data of the real-world POSITIVE study* Poster Presentation [P3344]: (ENCORE) Impact of patient psoriasis on partner well-being in a real-world setting: 52- week interim data of the phase IV POSITIVE study* * Indicates data sponsored by Almirall; Sun Pharma and Almirall operate under a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.2,3,4 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. About THRIVE-AA1 and THRIVE-AA2 trial design THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650) were randomized, double-blind, placebo-controlled clinical trials in 1223 adult patients ages 18-65 with severe alopecia areata at sites in the U.S., Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) score. Patients were randomized to receive either 8 mg twice daily or 12 mg twice daily of deuruxolitinib or placebo for 24 weeks. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. Patients enrolled in THRIVE-AA1 and THRIVE-AA2 were required to have at least 50 percent scalp hair loss due to alopecia areata, as measured by SALT. A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients in THRIVE-AA1 and THRIVE-AA2 was approximately 85.9 and 87.9 respectively. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. ILUMYA Important Safety Information Please click here for Full Prescribing Information and Medication Guide. INDICATION ILUMYA (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. CONTRAINDICATIONS ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients. WARNINGS AND PRECAUTIONS: Hypersensitivity: Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy. Infections: ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves. Pretreatment Evaluation for Tuberculosis: Evaluate patients for tuberculosis (TB ) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment. Immunizations: Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines. Adverse Reactions: The most common (≥1 % ) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or . Disclaimer Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. References Cleveland Clinic. Alopecia Areata. . Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. 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