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Highlights

  • Japan approves Dupixent® for chronic obstructive pulmonary disease (COPD) in adults.
  • Approval follows results from the BOREAS Phase 3 trial, showing improved lung function.
  • Dupixent® is already approved for multiple conditions, including asthma and atopic dermatitis.

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing and manufacturing authorization for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) in adults whose condition is not well-managed with existing therapies. This approval follows promising data from the BOREAS Phase 3 trial, which assessed Dupixent’s effectiveness when added to standard inhaled therapies in patients with uncontrolled COPD and elevated eosinophil levels.

In the BOREAS trial, Dupixent significantly reduced the frequency of exacerbations and improved lung function compared to placebo. Safety results were consistent with Dupixent’s known safety profile, with injection site reactions being the most common side effect. The findings were also published in The New England Journal of Medicine, alongside results from the NOTUS Phase 3 trial, further supporting the treatment’s potential benefits.

Dupixent is already approved in Japan for multiple conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, and chronic spontaneous urticaria (CSU). The approval for COPD adds to its growing list of indications. Worldwide, Dupixent is approved for COPD treatment in over 45 countries, including the European Union’s 27 member states.

COPD is a progressive lung disease characterized by a decline in lung function, affecting millions globally. Despite treatment, many COPD patients continue to experience exacerbations, leading to hospitalizations and a reduced quality of life. Dupixent’s approval in Japan provides an additional treatment option for adults struggling with uncontrolled COPD and offers hope for better management of this challenging condition.