FDA to review Dupixent sBLA in asthma

The US Food and Drug Administration has accepted for review the supplemental Biologics License Application (sBLA) of Dupixent (dupilumab) as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with moderate-to-severe asthma.

Under the Prescription Drug User Fee Act, the target action date for an FDA decision is October 20, 2018, say the drug’s developers, US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and France’s Sanofi (Euronext: SAN).

The application is supported by clinical data from 2,888 adults and adolescents who participated in three pivotal trials from the LIBERTY ASTHMA clinical development program. Detailed results from the Phase III QUEST and VENTURE trials will be submitted for presentation at medical meetings later this year.