Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi SA (NASDAQ:SNY) received marketing authorization in Japan for their blockbuster drug Dupixent to treat severe asthma in children aged 6 to 11.
The decision by the Ministry of Health, Labour and Welfare expands the medicine's reach in a key Asian market where it was previously restricted to patients 12 and older.
The approval targets children with severe or refractory bronchial asthma that remains inadequately controlled by existing therapies.
It is underpinned by data from the global Phase 3 VOYAGE program and the EXCURSION extension study.
In these trials, Dupixent, when added to standard-of-care, was shown to reduce severe asthma exacerbations by 54% to 65% compared to a placebo.
Crucially for pediatric outcomes, the drug also demonstrated significant improvements in lung function, with gains ranging from 4.68% to 5.32% over placebo.
A specific sub-study of Japanese pediatric patients mirrored these results, showing enhanced lung function at the 12-week mark and a low rate of annual exacerbations.
Dupixent, which targets the IL-4 and IL-13 pathways to curb type 2 inflammation, has become a cornerstone of the Regeneron-Sanofi partnership.
This latest regulatory win in Japan follows similar pediatric expansions in the U.S. and Europe, further solidifying the drug's position as a primary biologic option for younger populations suffering from chronic respiratory conditions.