Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The Ministry of Health, Labour and Welfare (MHLW) in Japan has authorised Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) for treating chronic obstructive pulmonary disease (COPD) in adults.
The therapy is available in Japan in a 300 mg dose as a pre-filled syringe or pen. Credit: Diana Polekhina on Unsplash.
Subscribe to our email newsletter
This new option is intended for patients whose COPD is not sufficiently controlled with existing treatment.
COPD is a chronic respiratory disease that progressively impairs lung function and is the fourth leading cause of death globally.
The marketing and manufacturing authorisation of Dupixent in Japan provides a new treatment avenue for those suffering from this debilitating condition.
The decision by the MHLW was informed by the BOREAS Phase III trial, which demonstrated that Dupixent, when added to maximal standard-of-care inhaled therapy, reduced exacerbations and improved function of lungs in adults with uncontrolled COPD and high blood eosinophils.
Dupixent’s safety profile in the trial was found to be consistent with its known safety profile in other approved indications.
The most commonly reported adverse event was an injection site reaction.
In Japan, Dupixent is already approved for use in certain patients with atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), asthma, prurigo nodularis and chronic spontaneous urticaria (CSU).
Now approved for COPD, it is available in Japan in a 300 mg dose as a pre-filled syringe or pen.
Dupixent’s mechanism of action involves inhibiting the signalling of interleukin-4 (IL4) and interleukin-13 (IL13) pathways, targeting a specific population with evidence of type-2 inflammation.
Globally, Dupixent for COPD treatment has been approved in over 45 countries, including all 27 member countries of the European Union (EU).
It is being jointly developed by Sanofi and Regeneron under a wordwide collaboration agreement.
