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SEPTEMBER 29, 2022

FDA Grants Dupixent a New Indication for Prurigo Nodularis

By PPN Staff

The FDA granted a new indication for dupilumab (Dupixent, Sanofi/Regeneron) to treat adults with prurigo nodularis. The medication is the first FDA-approved treatment for this chronic skin disease.

The new indication is based on data from the phase 3, placebo-controlled PRIME and PRIME2 trials. Participants received 300 mg of dupilumab every two weeks following an initial dose of 600 mg.

By week 24 in the trials, 60% and 58% of patients in the dupilumab groups experienced a reduction