Big Molecule Watch
March 29, 2017

FDA Approves Sanofi and Regeneron’s Dupixent (dupilumab)

Sanofi and Regeneron announced yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.  As we reported last week, Sanofi and Regeneron have filed a declaratory judgment action seeking a ruling that Dupixent® does not infringe Amgen’s U.S. Patent 8,679,487, as well as a petition for inter partes review challenging the patentability of the ‘487 patent.