Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils
Regeneron Pharmaceuticals, and Sanofi announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.
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The approval in Japan was based on data from the landmark pivotal BOREAS Phase 3 trial. The trial evaluated Dupixent added to background maximal standard-of-care inhaled therapy (with nearly all patients on triple therapy or double therapy if inhaled corticosteroids were contraindicated) in adults with uncontrolled COPD and elevated blood eosinophils. In the trial, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The adverse event most commonly reported with Dupixent was injection site reaction. Results from BOREAS and the replicate NOTUS Phase 3 trial were published in The New England Journal of Medicine.
In addition to COPD, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and chronic spontaneous urticaria (CSU). Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the European Union (EU).
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About COPD
COPD is a chronic respiratory disease that damages the lungs and causes progressive lung function decline, and is the fourth leading cause of death worldwide. Symptoms include persistent cough, excessive mucus production and shortness of breath that may impair the ability to perform routine daily activities, which may lead to sleep disturbances, anxiety and depression. COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid medicine and/or antibiotics. Smoking and exposure to noxious inhaled particles are key risk factors for COPD, and even individuals who stop smoking can still have progressive lung disease. About half of COPD patients continue to experience exacerbations despite being on triple inhaled therapy. Patients with COPD and elevated eosinophils have an increased risk of exacerbations and COPD-related hospitalizations within a year.
About Regeneron and Sanofi’s COPD Clinical Research Program
Regeneron and Sanofi are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through the clinical assessment of two biologics, Dupixent and itepekimab.
Dupixent is a first-in-class biologic that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, and the program focuses on a specific population of people with evidence of type 2 inflammation. Itepekimab is a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33), an initiator and amplifier of broad inflammation in COPD.
Itepekimab is currently under clinical investigation for COPD in two Phase 3 trials and its safety and efficacy have not been evaluated by any regulatory authority.
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Source – GlobalNewswire
