Sanofi Dupixent approved in Japan for COPD
Dupixent is intended for injection under the skin (subcutaneous injection) and is given every other week.
Paris: Sanofi has announced that the Ministry of Health, Labour and Welfare 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.
The approval in Japan was based on data from the landmark BOREAS phase 3 study. The study 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 study, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the study were generally consistent with the known safety profile of Dupixent in its approved indications. Results from BOREAS and the replicate NOTUS phase 3 study 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 EU.
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.
Dupixent (dupilumab) is available in Japan in a 300 mg dose as a pre-filled syringe or pre-filled pen and is now available for COPD. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every other week. It can be given in a clinic or at home by self-administration after training by a healthcare professional.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL4 and IL13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type-2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type-2 inflammation that plays a major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, CSU, and COPD in different age populations. More than one million patients are being treated with Dupixent globally.
