FDA to review Dupixent sBLA in asthma

2 March 2018

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).

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