Dupixent approved as first biologic medicine in Japan for patients with COPD

The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Sanofi and Regeneron’s 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. The most commonly reported adverse event with Dupixent was injection site reaction. 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.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

Related news