Healthcare

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) Receives Approval for Dupixent® in Japan for COPD Treatment

Fri 28 Mar 25, 08:25 AM | Team Kalkine

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Highlights

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.

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