FDA Approves Dupixent for Atopic Dermatitis

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FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

Updated on March 29, 2017

On March 28, 2017 FDA approved Dupixent (dupilumab) for the treatment of adults with moderate to severe atopic dermatitis, Regeneron and Sanofi said in a statement. The monoclonal antibody (mAb) comes in a prefilled syringe, and works by inhibiting interleukin-4 (IL-4) and IL-3. The companies claim Dupixent is the “first and only biologic medicine” approved for the disease.

The Dupixent approval comes in the wake of a preemptive lawsuit filed by Sanofi/Regeneron on March 20, 2017 in a federal court Boston, MA. According to court documents, the companies learned that Amgen, which holds a patent covering IL-4 inhibitors, had hired counsel to litigate a potential case involving an IL-4 inhibitor. Dupixent was the only IL-4 inhibitor expected to come to market soon, and therefore, Sanofi/Regeneron found it likely that Amgen was planning a patent challenge. As a result, Regeneron/Sanofi asked the court to issue a declaratory judgment of non-infringement on Amgen’s patent, allowing Regenerom/Sanofi to market Dupixent without risk of an infringement suit.

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The approval of Dupixent comes one day ahead of the drug’s March 29, 2017 PDUFA date. In an emailed statement to BioPharm International a spokesperson from Sanofi said "Dupixent will be available later this week in US to patients suffering from moderate to severe atopic dermatitis."

Source: Sanofi/Regeneron