French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) on Tuesday announced approval from Japan's Ministry of Health, Labour and Welfare for Dupixent (dupilumab) to treat children aged 6 to 11 years with severe or refractory bronchial asthma inadequately controlled by existing therapies.

This authorisation expands the drug's prior approval in Japan, which covered patients aged 12 years and older.

The decision was based on the global phase 3 VOYAGE study and supporting data from the EXCURSION extension, including Japanese paediatric patients, showing that Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% versus placebo. Dupixent is the first biologic to demonstrate lung function improvement in this age group in a randomised phase 3 trial and targets IL-4 and IL-13, key drivers of type 2 inflammation.

Dupixent is already approved in Japan for multiple inflammatory conditions and has been authorised in 50 countries worldwide for asthma in children aged 6 to 11 years. The therapy is being jointly developed by Sanofi and Regeneron and has been evaluated in more than 60 clinical studies involving over 10,000 patients.