Asthma, Exercise-Induced

WARREN, N.J., July 6, 2023 /PRNewswire/ -- Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as "Cipla"), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level. Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall. The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled. The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 17ml plain aluminium aerosol canister integrated with dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60. These 6 batches were distributed Nationwide to wholesalers and retailers. Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products. Consumers/distributors/retailers that have product from these 6 batches which are being recalled should stop using/return to place of purchase/discard. Consumers with questions about adverse reactions or quality problems regarding these 6 batches can contact Cipla Customer Service at 844- CIPLAUS (844-247-5287) M-F 8:30-5:00 EST, or email [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Cipla maintains stringent quality processes to assess quality defects and safety issues. Cipla conducts regular investigation and assessment by committees consisting of subject-matter experts, quality management, and medical safety experts. SOURCE Cipla

TEL AVIV, Israel & PARSIPPANY, N.J.--( BUSINESS WIRE )--Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that new data on its Digihaler System will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2023 Annual Meeting, being held February 24-27 in San Antonio, Texas. The data includes findings from the CONNECT2 clinical trial program as well as information on patients and healthcare professionals' real-world use of the smart inhaler system. The Digihaler System is the first and only smart inhaler system with built-in sensors that provide objective inhaler event data to help patients and their doctors support asthma management and develop personalized treatment plans. The data will be featured in five posters, which will highlight: Real-world Digihaler System usage patterns for patients The relationship between medication adherence and patients’ voluntary responses to a daily self-assessment (DSA) feature Barriers, facilitators, and HCP recommendations related to implementation of digital inhaler technology “The data we are presenting at AAAAI share meaningful insights for doctors and asthma patients about asthma management based on information provided by the Digihaler System,” said Tanisha Hill, Senior Medical Director, Respiratory and Digital Health Medical Lead at Teva. “Understanding trends around adherence and predictors of success in disease management are important to informing more personalized treatment.” Digihaler is a digital health system comprised of an electronic multi-dose dry powder smart inhaler, connected app, Digital Health Platform cloud solution and dashboard. Digihaler inhalers have built-in flow sensors that detect, record and store objective data showing how often and how well patients use their inhalers, as measured by inspiratory flow. Patients are able to view their data on the Digihaler app, including inhaler use patterns over time, and can share it with a healthcare provider to facilitate dialogue and personalize treatment discussions. Healthcare providers can also monitor the data on a dashboard with patient permission. As per the U.S. Food and Drug Administration (FDA) approved label, there is no evidence that the use of the app leads to improved clinical outcomes, including safety and efficacy. CONNECT2 The CONNECT clinical program evaluated the potential impact of Digihaler System on patient-provider interactions, adherence over time, inhaler technique and frequency of short-acting beta agonist (SABA) use. The CONNECT2 trial was conducted to assess the role of both the ProAir ® Digihaler (albuterol sulfate) inhalation powder and AirDuo ® Digihaler (fluticasone propionate and salmeterol) inhalation powder in the treatment of asthma as part of the Digihaler System. CONNECT2 was a 24-week open-label, multicenter, randomized, parallel group study that evaluated the impact of this Digihaler System on asthma management compared to standard of care (SoC) in 427 patients with asthma. Participants in the SoC group continued treatment with their current SoC asthma maintenance and reliever medications. Digihaler integrated inhalers transmit data wirelessly to a smartphone application (App), which allows for inhaler event tracking. The App includes a voluntary, non-respiratory-specific DSA. The DSA includes questions asking how a patient is feeling on a three-point scale ranging from sad to neutral to happy. The two CONNECT2 analyses that will be presented at AAAAI explore: The relationship between SABA use and patient self-assessment responses The relationship between medication adherence and patient self-assessment responses Real-World Digital Health Platform Analysis The Digihaler Digital Health Platform allows patients to track their inhaler events, and inhaler use, which is recorded as an event when the cap is opened or a patient inhales. The objective data is collected in the App and can be shared with physicians to help them make more informed treatment decisions. The poster that will be presented at AAAAI explores: Real-world usage patterns and data from a digital health platform Implementation Study The study was comprised of telephone interviews and web surveys with specialists who prescribed the digital inhaler to at least one of their patients with asthma or chronic obstructive pulmonary disease (COPD). The surveys and semi-structured interviews were used to evaluate barriers and facilitators to implementation from participants. Investigators utilized the consolidated framework for implementation research (CFIR) theoretical framework to better understand how the Digihaler System was used in clinical practice and report recommendations from early adopters of the technology. The two implementation research posters that will be presented at AAAAI explore: Theory-based implementation research to evaluate barriers and facilitators to the implementation of digital inhaler technology in clinical practice The real-world implementation of digital inhaler technology in clinical practice These poster presentations can be accessed by registering for the meeting. Teva-sponsored data to be presented includes: #P37 Real-World Inhaler Usage Patterns Obtained from a Digital Health Platform Session: Poster Presentations and Case Study Posters Date/Time: Friday, February 24 th , 3:15 PM – 4:15 PM #P487 Relationship Between SABA Use and Self-Assessment Responses in Patients with Asthma Session: Poster Presentations and Case Study Posters Date/Time: Sunday, February 26 th , 9:45 AM – 10:45 AM #P488 Relationship Between Medication Adherence and Self-Assessment Responses in Patients with Asthma Session: Poster Presentations and Case Study Posters Date/Time: Sunday, February 26 th , 9:45 AM – 10:45 AM #P504 Use of Theory-Based Implementation Research to Evaluate Barriers and Facilitators to Implementation of a Novel Digital Inhaler Technology in Clinical Practice Session: Poster Presentations and Case Study Posters Date/Time: Sunday, February 26 th , 9:45 AM – 10:45 AM #P511 Implementation of a Novel Digital Inhaler Technology in Real-World Clinical Practice: Experiences and Recommendations from Early Adopters Session: Poster Presentations and Case Study Posters Date/Time: Sunday, February 26 th , 9:45 AM – 10:45 AM ProAir Digihaler Indications and Usage ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. Important Safety Information About ProAir Digihaler Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy Please read the full Prescribing Information. AirDuo Digihaler Indications and Usage AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older. AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler. AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App. AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine. Important Safety Information About AirDuo Digihaler AirDuo Digihaler contains salmeterol. Long-acting beta 2 -agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems. Do not use AirDuo Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms. Do not use AirDuo Digihaler if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure. Do not use AirDuo Digihaler more often than prescribed. Do not take AirDuo Digihaler with other medicines that contain a LABA for any reason. Tell your healthcare provider about all the medicines you take and about all of your health conditions. AirDuo Digihaler can cause serious side effects, including: Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo Digihaler to help reduce your chance of getting thrush. Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur. Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo Digihaler). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include: feeling tired lack of energy weakness nausea and vomiting low blood pressure Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away. Serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash hives swelling of your face, mouth, and tongue breathing problems Effects on heart increased blood pressure a fast or irregular heartbeat chest pain Effects on nervous system tremor nervousness Bone thinning or weakness (osteoporosis) Slowed growth in children. A child's growth should be checked often. Eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler. Changes in laboratory blood values (sugar, potassium, certain types of white blood cells) Common side effects of AirDuo Digihaler include: Infection of nose and throat (nasopharyngitis) thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this. back pain headache cough These are not all the possible side effects of AirDuo Digihaler. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. Please see full Prescribing Information for AirDuo Digihaler. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of innovative and biopharmaceutical products. Learn more at www.tevapharm.com . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our digihaler products family, including ProAir Digihaler and AirDuo Digihaler; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO ® , AJOVY ® and COPAXONE ® , our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

Airsupra is the first and only rescue medication approved in the US for as-needed use to reduce risk of asthma exacerbations Approval based on successful Phase III trial programme conducted by Avillion in more than 4,000 patients under an exclusive clinical co-development agreement with AstraZeneca Continues Avillion's 100% success rate in clinical co-development partnerships across multiple therapeutic areas LONDON, Jan. 11, 2023 /PRNewswire/ -- Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the US Food and Drug Administration (FDA) has approved AstraZeneca's Airsupra (albuterol/budesonide, formerly known as PT027) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. Airsupra is a first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS). The US approval was based on positive results from a global Phase III clinical trial programme for Airsupra comprising four studies involving more than 4,000 patients (including the MANDALA and DENALI trials1,2), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca. Under its 2018 agreement, Avillion had regulatory responsibility including filing the New Drug Application (NDA) through to FDA approval in the US. Following this approval, AstraZeneca has the option, upon making certain financial payments to Avillion, to commercialise Airsupra in the US. This milestone continues Avillion's 100% successful rate in clinical co-development partnerships for the global pharmaceutical and biotech industry. In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms.1 The results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.1 In DENALI, Airsupra significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild to moderate asthma.2 The safety and tolerability of Airsupra in both trials were consistent with the known profiles of the components,1,2 with the most common adverse events including headache, oral candidiasis, cough and dysphonia.3 The co-development partnership between AstraZeneca and Avillion has recently expanded to include the BATURA study, a randomised Phase IIIb decentralised trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations. The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth. Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, US, said: "People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control. Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma. The approval of Airsupra means that, for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease." Allison Jeynes, MD, Chief Executive Officer of Avillion, said: "We're delighted that our clinical co-development programme with AstraZeneca has been successful and that Airsupra has been approved in the US as a new treatment option for asthma patients. The Airsupra approval continues our 100% success rate facilitating clinical co-development programmes with pharma companies, demonstrating the strong value our innovative model can provide to partners and the excellence and dedication of our international team. We've had an excellent working relationship with AstraZeneca and are excited to continue our partnership with the BATURA Phase IIIb study, which is looking to continue building the evidence base of Airsupra to reduce the risk of asthma exacerbations." The full press announcement from AstraZeneca on the US approval of Airsupra can be found here. Notes Asthma Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide,4 including over 25 million in the US.5 Patients with asthma experience recurrent breathlessness and wheezing, which varies over time, and in severity and frequency.6 These patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control.7,8 There are an estimated 136 million asthma exacerbations globally per year,9 including 10 million in the US;5 these are physically threatening and emotionally significant for many patients11 and can be fatal.4,11 Inflammation is central to both asthma symptoms7 and exacerbations.12 Many patients experiencing asthma symptoms use a SABA (e.g. albuterol) as a rescue medicine;13-15 however, taking a SABA alone does not address inflammation, leaving patients at risk of severe exacerbations,16 which can result in impaired quality of life,17 hospitalisation18 and frequent oral corticosteroid (OCS) use.18 Treatment of exacerbations with as few as 1-2 short courses of OCS are associated with an increased risk of adverse health conditions including type 2 diabetes, depression/anxiety, renal impairment, cataracts, cardiovascular disease, pneumonia and fracture.19 International recommendations from the Global Initiative for Asthma no longer recommend SABA alone as the preferred rescue therapy.6 MANDALA, DENALI and the CREST (Combination REliever STudies) programme The CREST clinical trial programme studied the efficacy and safety of PT027 and included the MANDALA,1,20,21 DENALI2,22,23 and TYREE25 Phase III trials. MANDALA1,20,21 was a Phase III, randomised, double-blind, multicentre, parallel-group, event-driven trial evaluating the efficacy and safety of Airsupra compared to albuterol on the time to first severe asthma exacerbation in 3,132 adults, adolescents, and children (aged 4–11 years) with moderate to severe asthma taking ICS alone or in combination with a range of asthma maintenance therapies, including long-acting beta2-agonists (LABA), leukotriene receptor antagonists (LTRA), long-acting muscarinic antagonists (LAMA) or theophylline. The trial comprised a two-to-four-week screening period, at least a 24-week treatment period and a two-week post-treatment follow-up period. Patients were randomly assigned to one of the following three treatment groups in a 1:1:1 ratio: Airsupra 180/160mcg (excluding children aged 4–11 years), albuterol/budesonide 180/80mcg or albuterol 180mcg, taken as an as-needed rescue medicine. Airsupra and the albuterol comparator were delivered in a pMDI using AstraZeneca's Aerosphere delivery technology. The primary efficacy endpoint was the time to first severe asthma exacerbation during the treatment period. Secondary endpoints included severe exacerbation rate (annualised), total systemic corticosteroid exposure (annualised), asthma control and health-related quality of life. Results from the positive MANDALA Phase III trial showed that Airsupra demonstrated a statistically significant reduction in the risk of a severe exacerbation versus albuterol rescue in patients with moderate to severe asthma1,21. Compared with albuterol rescue, Airsupra at the 180mcg albuterol/160mcg budesonide dose reduced the risk of a severe exacerbation by 27% (p<0.001) in adults and adolescents1,21. Primary and secondary endpoint results in adults and adolescents1,21 (pre-planned on-treatment efficacy analysis) aDeterioration of asthma requiring use of SCS for ≥3 days, or inpatient hospitalisation, or emergency room visit, that required SCS. bBefore discontinuation of randomised treatment or change in maintenance therapy. CI, confidence interval; SCS, systemic corticosteroid; SD, standard deviation Primary endpoint results in adults, adolescents, and children1,21 (pre-planned on-treatment efficacy analysis) aDeterioration of asthma requiring use of SCS for ≥3 days, or inpatient hospitalisation, or emergency room visit, that required SCS. bBefore discontinuation of randomised treatment or change in maintenance therapy. CI, confidence interval Adverse events (AEs) were similar across the treatment groups in the trial and consistent with the known safety profiles of the individual components, with the most common AEs including nasopharyngitis and headache.1,22 DENALI2,23,24 was a Phase III, randomised, double-blind, placebo-controlled, multicentre, parallel-group trial evaluating the efficacy and safety of Airsupra compared to its components albuterol and budesonide on improvement in lung function in 1,001 adults, adolescents, and children aged 4–11 years with mild to moderate asthma previously treated either with SABA as-needed alone or in addition to regular low-dose ICS maintenance therapy. The trial comprised a two-to-four-week screening period, a 12-week treatment period and a two-week post-treatment follow-up period. Patients were randomly assigned to one of the following five treatment groups in a 1:1:1:1:1 ratio: Airsupra 180/160mcg four times daily (excluding children aged 4–11 years), albuterol/budesonide 180/80mcg four times daily, albuterol 180mcg four times daily, budesonide 160mcg four times daily (excluding children aged 4–11 years) and placebo four times daily. Airsupra, the albuterol and budesonide comparators and placebo were delivered in a pMDI using AstraZeneca's Aerosphere delivery technology. The dual primary efficacy endpoints were change from baseline in FEV1 area under the curve 0-6 hours over 12 weeks of Airsupra compared to budesonide to assess the effect of albuterol and change from baseline in trough FEV1 at Week 12 of Airsupra compared to albuterol to assess the effect of budesonide. Secondary endpoints included the time to onset and duration of response on day one, number of patients who achieved a clinically meaningful improvement in asthma control from baseline at Week 12 and trough FEV1 at Week 1. In the trial, Airsupra demonstrated a statistically significant improvement in lung function measured by forced expiratory volume in one second (FEV1), compared to the individual components albuterol and budesonide, and compared to placebo in patients with mild to moderate asthma aged 12 years or older. Onset of action and duration of effect were similar for Airsupra and albuterol. The safety and tolerability of Airsupra in DENALI was consistent with the known profiles of the components. About Avillion Avillion offers pharma partners an innovative model providing additional funding and clinical development expertise, to maximise the potential of new and existing assets. With deal sizes ranging from $50M–$600M, Avillion takes on the full clinical and regulatory risk, focusing on the speed and quality of trial execution. Typically supporting programs post proof-of-concept through to registration and with an agnostic approach to therapy area, Avillion prides itself in adding value around operational expertise while being backed by established long-term investors. Avillion was founded in 2012 and is backed by Abingworth and Blackstone Life Sciences (previously Clarus Ventures). The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth. For more information, please visit us at References Papi A, et al. Albuterol–Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. N Engl J Med 2022; 386 (22): 2071-2083. Chipps BE, et al. Efficacy and safety of albuterol/budesonide (PT027) in mild-to-moderate asthma: Results of the DENALI study. Am J Respir Crit Care Med 2022; 205: A3414. Abstract. Available at: [Last accessed: November 2022]. Airsupra (albuterol/budesonide) US prescribing information; 2023. The Global Asthma Network. The Global Asthma Report 2022. [Online]. Available at: [Last accessed: November 2022]. CDC. Most Recent National Asthma Data. [Online]/ Available at: . [Last accessed: November 2022]. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2022. Available at: . [Last accessed: November 2022]. Price D, et al. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 24: 14009. Papi A, et al. Relationship of inhaled corticosteroid adherence to asthma exacerbations in patients with moderate-to-severe asthma. J Allergy Clin Immunol Pract. 2018; 6 (6): 1989-98.e3. AstraZeneca Pharmaceuticals. Data on File. Budesonide/formoterol Data on File: Annual Rate of Asthma Exacerbations Globally. (REF-173201) Sastre J, et al. Insights, attitudes, and perceptions about asthma and its treatment: a multinational survey of patients from Europe and Canada. World Allergy Organ J. 2016; 9: 13. Fernandes AG, et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40 (4): 364-372. Wark PA, et al. Asthma exacerbations· 3: pathogenesis. Thorax. 2006; 61 (10): 909-15. Johnson DB, et al. Albuterol. 2022 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan–. PMID: 29489143. Montemayor T, et al. Albuterol: Often Used and Heavily Abused. Respiratory Care November 2021, 66 (Suppl 10) 3603775 ClinCalc.com. Albuterol: Drug Usage Statistics, US 2013 – 2020. Available at: . [Last accessed: November 2022]. Nwaru BI, et al. Overuse of short-acting β2-agonists in asthma is associated with increased risk of exacerbation and mortality: a nationwide cohort study of the global SABINA programme. Eur Respir J. 2020; 55 (4): 1901872. Lloyd A, et al. The impact of asthma exacerbations on health-related quality of life in moderate to severe asthma patients in the UK. Prim Care Respir J. 2007; 16 (1): 22-7. Bourdin A, et al. ERS/EAACI statement on severe exacerbations in asthma in adults: facts, priorities and key research questions. Eur Respir J. 2019; 54 (3): 1900900. Price DB, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy. 2018; 11: 193–204. Chipps BE, et al. Evaluation of the Efficacy and Safety of As-Needed PT027 Budesonide/Albuterol MDI) Compared to As-Needed Albuterol MDI in Adults and Children 4 Years of Age or Older with Uncontrolled Moderate to Severe Asthma: Design of the MANDALA Study. Am J Respir Crit Care Med. 2020; 201: A3015. Papi A, et al. Efficacy and safety of as-needed albuterol/budesonide versus as-needed albuterol in adults, adolescents and children aged ≥4 years with moderate-to-severe asthma: Results of the MANDALA study. American Thoracic Society International Conference 2022. Oral Presentation. Abstract A3413 during B93. BREAKTHROUGHS IN PEDIATRIC AND ADULT ASTHMA CLINICAL TRIALS Clinicaltrials.gov. A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (DENALI). Available at . [Last accessed: November 2022]. AstraZeneca Pharmaceuticals. Data on File. DENALI clinical trial protocol Data on File (ID: 121792). LaForce C, et al. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol. 2022; 128: 169-177. SOURCE Avillion LLP