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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
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.
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."