Cutaneous hypersensitivity

U.S. Food and Drug Administration approves Zenrelia, a once-daily oral JAK inhibitor for dogs with allergic and atopic dermatitis Elanco enters the estimated $1.7 billion global canine dermatology market, highly accretive to existing portfolio In a head-to-head study, Zenrelia was shown to be at least as effective as the market incumbent JAK inhibitor at the primary end point, with an additional endpoint at which Zenrelia got 77% of dogs to clinical remission of itch, compared to 53% of dogs treated with Apoquel® (oclacitinib tablet)1* Zenrelia launch begins in U.S. with Elanco now taking orders; product expected to ship in coming days GREENFIELD, Ind., Sept. 19, 2024 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug Administration (FDA) has approved Zenrelia™, a safe, highly effective, and convenient once-daily oral JAK inhibitor for control of pruritus (itching) associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Elanco announces FDA approval and launch of Zenrelia™ (ilunocitinib tablets), offering an effective, safe solution in canine dermatology; unlocks new solution to treat 17 million itchy dogs with just one daily dose Elanco conducted a head-to-head noninferiority study comparing the efficacy and safety of Zenrelia and Apoquel for submission in the European Union. Itching is one of the top reasons pet owners bring their dog to the veterinarian, and pet owners and veterinarians want more canine dermatology options. Approximately 17 million dogs suffer from allergic skin disease, including atopic dermatitis, food allergies or flea sensitivity2. Among pet owners who say their dog's itch is not under control, 60% say they've tried treating the itch, but nothing works.3 The approval of Zenrelia represents an important advancement in treating itchy dogs suffering from chronic, acute or seasonal itch and inflammation in a single, once daily tablet from the start. Zenrelia targets itch where it starts by blocking the pathways involved in allergic itch to break the itch-scratch cycle.4 Zenrelia offers visible improvement from the first dose and minimizes the risk of "rebound itch" which affects many dogs treated with the competitive JAK inhibitor.5-10 "Today is a historic day for Elanco with our first of several expected entries into the fast-growing global canine dermatology market, bringing veterinarians and pet owners a highly effective new solution that got more dogs back to normal levels of itch in a head-to-head study with the current JAK inhibitor on the market1*," said Jeff Simmons, President and CEO, Elanco Animal Health. "We are excited to offer veterinarians and pet owners a solution that can relieve the burdens of itch, while also becoming just the second animal health company to offer veterinarians a comprehensive portfolio, including parasiticides, vaccines, pain and other therapeutics, and now, dermatology." Promising Results from a Head-to-Head Study1 Elanco conducted a head-to-head noninferiority study comparing the efficacy and safety of Zenrelia and Apoquel for submission in the European Union. The randomized, double-blind study of 338 client-owned dogs with confirmed atopic dermatitis was conducted across 25 study sites in four countries. The study shows one daily dose of Zenrelia is at least as effective as the market incumbent JAK inhibitor at the primary end point on Day 28. Additionally, there were several promising additional endpoints*: Zenrelia provided consistently greater relief from itch and skin lesions over time, with once-daily dosing from the start while rebound itch was observed in Apoquel treated dogs after dosing decreased to once daily after Day 14. Zenrelia got more dogs back to normal levels of itch by the end of the study, with 77% of Zenrelia treated dogs achieving clinical remission of itch, compared to 53% of Apoquel treated dogs. The difference in treatment response was recognized by owners and veterinarians, with both groups rating Zenrelia higher than Apoquel for overall response to treatment from Day 28 through to Day 112. The adverse event profile was similar between the Zenrelia and Apoquel groups. Veterinarians And Pet Owners Need More Options Research shows that nearly 70% of veterinarians would be willing to stock another dermatology product2 as there are still too many dogs that aren't getting itch relief and many pet owners that would benefit from a more affordable option. "We're dedicated to solving these unmet needs in canine dermatology," said Bobby Modi, Executive Vice President, U.S. Pet Health and Global Digital Transformation. "Zenrelia's once-daily dosing is more convenient and will be affordable for pet owners with the launch list price about 20% less for nearly all dogs compared to the current JAK inhibitor. Pet owners will appreciate even greater savings in the first 14 days for Zenrelia given its single vs. twice daily dosing. Very importantly, Zenrelia minimizes the opportunity for rebound itch given its consistent once daily dosing compared to the market incumbent."1, 5-10* Take for example, Trooper, a one-year-old Yorkshire Terrier who enrolled in the Zenrelia clinical trial. Prior to participating in the clinical trial, Trooper's itch level was 10 out of 10 on the pruritus visual analog scale (PVAS), a validated observation scale for canine itch. By the end of the first two weeks of treatment, he was back to a normal itch level of 1.9 and finished the clinical trial with an itch level of 1.1.** A PVAS score of less than 2 is considered a normal level of itch, also referred to as clinical remission of itch. You can read more about Trooper's story here. "I was excited to participate as a clinical investigator in the Zenrelia field study because it is clear we need more treatment options for itchy dogs," said Dr. Tom Lewis, veterinarian and founder of Dermatology for Animals, a group of veterinary dermatology clinics committed to caring for pets with allergies. "I saw amazing results during the clinical field study and am eager to get many patients started on Zenrelia. Watching dogs get back to normal quickly and seeing the bond restored between the dog and pet parent was incredibly rewarding." Demonstrated Safety The safety of Zenrelia has been demonstrated in multiple toxicity and clinical safety studies. The required margin of safety study for Zenrelia was conducted in healthy dogs dosed with placebo, 1, 2, 3 or 5 times the label dose daily for six months. All dogs completed the study with no serious adverse events. The Zenrelia label includes a boxed warning on safety related to concurrent vaccine administration based on the results of a vaccine response study. In this study, eight, 10-month-old laboratory beagles received primary vaccinations while being treated with Zenrelia at 3X the label dose. Two dogs were immunosuppressed and euthanized during the study. Antibody responses were evaluated following vaccination. All but one dog responded successfully to modified live vaccines, and two of six dogs responded to inactivated Rabies vaccine at the primary endpoint. Dogs should be up to date on vaccinations prior to starting Zenrelia. It's important for veterinarians to read the entire package insert, including the Boxed Warning, before prescribing Zenrelia. "Zenrelia has been demonstrated to be safe and highly effective in a number of studies," said Dr. Mara Tugel, veterinarian and Dermatology Medical Strategic Lead at Elanco. "We recognize that veterinarians need clinically relevant data to guide treatment choices, and plan to pursue additional studies to evaluate vaccine response in Zenrelia-treated dogs. We will continue to work to improve the label over time." Veterinarians in the U.S. can learn more and place orders for Zenrelia now at Zenreliaforvets.com. Orders are expected to begin shipping in the coming days. Elanco will conduct a conference call on Friday, September 20, 2024 at 8:00 am eastern time to discuss the Zenrelia approval with the investment community and other interested parties. A live webcast of the conference call can be accessed through the link that will be posted on Elanco's website at . A replay will also be available on the website shortly following the call. ABOUT ELANCO Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at . INDICATIONS is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. IMPORTANT SAFETY INFORMATION Read the entire package insert before using this drug, including the boxed warning. For Full prescribing information call 1 888 545 5973 or visit . WARNING: VACCINE-INDUCED DISEASE AND INADEQUATE IMMUNE RESPONSE TO VACCINES. Based on results of the vaccine response study, dogs receiving Zenrelia are at risk of fatal vaccine-induced disease and inadequate immune response to vaccines. Discontinue Zenrelia for at least 28 days to 3 months prior to vaccination and withhold Zenrelia for at least 28 days after vaccination. Dogs should be up to date on vaccinations prior to starting Zenrelia. Do not use in dogs less than 12 months old or dogs with a serious infection. Monitor dogs for infections because Zenrelia may increase susceptibility to opportunistic infections. Neoplastic conditions (benign and malignant) were observed during clinical studies. Consider the risks and benefits of treatment in dogs with a history of recurrence of these conditions. The most common adverse reactions were vomiting, diarrhea and lethargy. Zenrelia has not been evaluated in breeding, pregnant, or lactating dogs and concurrent use with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents has not been tested. For full prescribing information see package insert. Forward-Looking Statements: TBD Zenrelia, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Apoquel is a trademark of Zoetis Services, LLC. © 2024 Elanco or its affiliates. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning Zenrelia as a treatment for dogs with allergic dermatitis and timeline for launch, commercial uptake, as well as future studies, publications and other milestones related to Zenrelia, and reflects Elanco's current beliefs and expectations. However, as with any animal health pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that future studies will receive regulatory approval, or that Elanco will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Elanco's expectations, see Elanco's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Elanco undertakes no duty to update forward-looking statements to reflect events after the date of this release. Investor Contact: Katy Grissom (317) 273-9284 [email protected] Media Contact: Season Solorio (765) 316-0233 [email protected]   References: Elanco Animal Health. Data on File. AVMA Sourcebook. Elanco, Dermatology Products SOV Study, 2023 Elanco and FleishmanHillard TRUE Global Intelligence Survey. Elanco Animal Health. Data on File. Cosgrove SB, et al. A blinded, randomized, placebo-controlled trial of efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis. Vet Dermatol, 2013; 24: 587-e142. Little PR, et al. A blinded, randomized clinical trial comparing the efficacy and safety of oclacitinib and ciclosporin for the control of atopic dermatitis in client-owned dogs. Vet Dermatol, 2015; 26: 23-e8. Fukuyama T, et al. Demonstration of rebound phenomenon following abrupt withdrawal of the JAK1 inhibitor oclacitinib. European Journal of Pharmacology, 2017; 794: 20-26. Takahashi J, et al. Efficacy and safety of 0.0584% hydrocortisone aceponate topical spray and systemic oclacitinib combination therapy in dogs with atopic dermatitis: a randomized, double-blinded, placebo-controlled trial. Vet Dermatol, 2021; 32: 119-e35. Denti D, et al. Prolonged twice-daily administration of oclacitinib for the control of canine atopic dermatitis: a retrospective study of 53 client-owned atopic dogs. Vet Dermatol, 2022; 33: 149-e42. Olivry T, et al. A randomized controlled trial testing the rebound-preventing benefit of four days of prednisolone during the induction of oclacitinib therapy in dogs with atopic dermatitis. Vet Dermatol, 2023; 34: 99-106. *Zenrelia was as effective as Apoquel at the primary study endpoint (Day 28). Additional outcomes (P≤0.05) included: proportion of dogs achieving PVAS <2; Mean PVAS and CADESI-4 scores, and veterinary and owner assessments of overall response to treatment. Additional endpoint P values are not adjusted for multiple testing; therefore, caution should be exercised in interpretation. ** Individual results may vary. In the U.S. Allergic Dermatitis and Atopic Dermatitis field studies, the proportion of treated dogs achieving normal itch levels (PVAS <2) after 14 days was 38.4% and 32.8%, respectively. SOURCE Elanco Animal Health WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

DALLAS, May 17, 2024 /PRNewswire/ -- American Skin Association (ASA) announced the recipients of the 2024 Inaugural Founders Award and the 2024 Research Achievement Awards at the 2024 Society for Investigative Dermatology (SID) Annual Meeting. For over three decades, ASA has honored members of the dermatology community who embody the characteristics that made the late Dr. David Martin Carter an inspiration to dermatologists, investigators, and medical students throughout the world. Dr. Carter and ASA's late co-founder, Dr. George Hambrick, worked tirelessly to grow the organization into a leading force to defeat melanoma, skin cancer and other skin diseases. This year, the organization is presenting the first ever Founders Award to highlight the enormous contributions of both Dr. Carter and Dr. Hambrick to the field of dermatology. The 2024 Inaugural Founders Award was presented to Kim Yancey, MD of UT Southwestern Medical Center. Dr. Yancey is a professor and the former Chairman of the Department of Dermatology at UT Southwestern Medical Center. He has been a National Institutes of Health-funded researcher for more than 25 years. An eminent dermatologist, medical scientist, and lecturer, Dr. Yancey has devoted much of his career to mentoring the next generation of dermatologists. He is also a distinguished author, editor, and scholar. ASA is proud to recognize his four decades of teaching, leadership, and investigative research in the field of dermatology. "Congratulations to Dr. Yancey and the 2024 Research Achievement Award recipients. We are honored to recognize these outstanding physicians in the field of dermatology for their vital work," said Howard P. Milstein, Chairman of ASA. "We are excited to present the 2024 Inaugural Founders Award to Dr. Kim Yancey," said David A. Norris, MD, President of ASA. "Dr. Yancey is the first honoree to receive this reimagined, prestigious award. Throughout his distinguished career in dermatology, he has prepared a generation of young scientists for careers in dermatology." ASA's Research Achievement Awards were instituted in 1989 to identify established scientists in investigative dermatology and cutaneous biology. This year, ASA acknowledged individuals who significantly progressed research in autoimmune and inflammatory skin conditions, vitiligo, skin cancer, melanoma, pigment cell disorders, psoriasis, and translational research, as well as community education and outreach. The following 2024 Research Achievement Awards were presented: 2024 Research Achievement Award in Psoriasis Joseph F. Merola, MD, MMSc, FAAD, FACR UT Southwestern Medical Center 2024 Research Achievement Award in Autoimmune & Inflammatory Skin Disorders and Vitiligo David Fiorentino, MD, PhD Stanford Medicine 2024 Research Achievement Award in Skin Cancer, Melanoma and Pigment Cell Disorders Madeleine Duvic, MD MD Anderson Cancer Center, The University of Texas 2024 Research Achievement Award in Discovery Thomas S. Kupper, MD, FAAD Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School 2024 Research Achievement Award in Translational Research Laura Korb Ferris, MD, PhD University of Pittsburgh 2024 Research Achievement Award in Community Education/Outreach SPOTS - Sun Protection Outreach Teaching by Students Sofia Chaudhry, MD, St. Louis University School of Medicine M. Laurin Council, MD, MBA, FAAD, FACMS, Washington University School of Medicine in St. Louis "We are excited to present the Research Achievement Awards this year to such exceptional doctors. Drs. Merola, Fiorentino, Duvic, Kupper, Ferris, Chaudhry, and Council have all made impressive contributions in their respective fields. ASA is pleased to celebrate their many exciting achievements," said David A. Norris, MD. ABOUT AMERICAN SKIN ASSOCIATION A unique collaboration of patients, families, advocates, physicians and scientists, ASA has evolved over nearly four decades as a leading force in efforts to defeat melanoma, skin cancer and other skin diseases. Established as a 501(c)(3) organization to serve the now more than 100 million Americans – one-third of the U.S. population – afflicted with skin disorders, the organization's mission remains to: advance research, champion skin health – particularly among children, and drive public awareness about skin disease. For more information, visit americanskin.org. American Skin Association has earned Candid's 2024 Seal of Platinum Transparency and Four-Star Rating from Charity Navigator. SOURCE American Skin Association

Dovato is now the first and only oral, two-drug, single-tablet regimen available for people aged 12 and older living with HIV, a population in need of additional treatment options DURHAM, N.C.--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.1 In the U.S., 20 percent of new HIV diagnoses in 2020 were among young people aged 13-24.2 This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12- and 18-years old living with HIV and underscores ViiV Healthcare’s ongoing commitment to bringing more therapeutic options to young people. Lynn Baxter, Head of North America at ViiV Healthcare, said: "This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment. As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.” The approval is supported by data from the DANCE study which evaluated Dovato in treatment-naïve adolescents as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults).1 Results from the DANCE study, which included adolescents between 12- and 18-years old weighing at least 25 kg with HIV-1 RNA 1000 to ≤500,000 c/mL, showed that 26/30 participants achieved and maintained viral suppression at Week 48.1 The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults.1 Exposures for components of Dovato were higher but were not clinically significant.1 About Dovato (dolutegravir/lamivudine)1,3 Dovato is a once-daily, oral, two-drug, single-tablet regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (50 mg) with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (300 mg). Dovato contains two medicines to inhibit the viral life cycle at two different sites. INSTIs, like dolutegravir inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle. The principal mode of action of lamivudine, an NRTIs, is inhibition of reverse transcriptase via DNA chain termination. Dovato is approved in the U.S., Europe, Japan, Australia and other countries worldwide. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About the DANCE Study DANCE (NCT03682848) is an ongoing phase 3b, single-arm, multicenter, open-label study evaluating once-daily, fixed-dose combination of Dovato (50 mg/300 mg) as initial ARV therapy for adolescents aged ≥12 to <18 years and weighing ≥25 kg, with HIV-1 RNA 1000 to ≤500,000 c/mL. The primary endpoint assessed proportions achieving HIV-1 RNA <50 c/mL at Week 48. A total of 32 participants were enrolled across nine centers from Thailand, Kenya, and South Africa.1 DOVATO (dolutegravir and lamivudine) tablets INDICATION DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. IMPORTANT SAFETY INFORMATION BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment. Contraindications Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine Do not use DOVATO in patients receiving dofetilide Warnings and precautions Hypersensitivity Reactions: Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn Monitoring for hepatotoxicity is recommended Embryo Fetal Toxicity: Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects Pregnancy testing is recommended before initiation of DOVATO. Individuals of childbearing potential should be counseled on the consistent use of effective contraception Lactic Acidosis and Severe Hepatomegaly With Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including lamivudine. Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions). Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO. Adverse reactions The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%). Drug interactions Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food Use in specific populations Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Advise individuals of childbearing potential of the potential risk of neural tube defects. Assess the risks and benefits of DOVATO and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester of pregnancy or if pregnancy is confirmed in the first trimester Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant Females and Males of Reproductive Potential: Pregnancy testing is recommended before initiation of DOVATO. Counsel individuals of childbearing potential taking DOVATO on the consistent use of effective contraception Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C) About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in the company's Annual Report on Form 20-F for 2023. Registered in England & Wales: GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: GSK plc 980 Great West Road Brentford, Middlesex United Kingdom TW8 9GS ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References Dovato US Prescribing Information. Available at: . Accessed April 2024. “HIV Information and Youth.” Centers for Disease Control and Prevention. . Accessed April 2024. Dovato EU Summary of Product Characteristics. February 2024. Available at: . Accessed April 2024.