Approvals

Japan’s Ministry of Health, Labour and Welfare has authorised the marketing and manufacturing of Sanofi and Regeneron’s chronic obstructive pulmonary disease (COPD) treatment Dupixent (dupilumab).

The decision adds to approvals the company has received in more than 45 countries worldwide, including the 27 member countries of the EU, and covers Dupixent’s use in adults, whose COPD is inadequately controlled by existing therapy.

The new Japanese approval was based on data from the BOREAS phase 3 study, which found that Dupixent significantly reduced exacerbations of symptoms and improved lung function compared to placebo.

The study analysed Sanofi and Regeneron's Dupixent when added to background maximal standard-of-care inhaled therapy in adults with uncontrolled COPD and elevated blood eosinophils. The results of the trial were published in The New England Journal of Medicine.

The decision by the Ministry of Health, Labour and Welfare adds increase Dupixent’s potential market, following the drug’s earlier approvals in Japan for certain patient populations in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and chronic spontaneous urticaria (CSU).

Meanwhile, Dupixent has won US approval for chronic spontaneous urticaria in adults and adolescents who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

Regeneron’s chief scientific officer George Yancopoulus said: “Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease.

“With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions.”