Sanofi, Regeneron win FDA label expansion for Dupixent in chronic, skin condition
Grandbrothers


The FDA has approved Dupixent, developed by Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) (OTCPK:SNYNF) (GCVRX), for adults with prurigo nodularis, a chronic, inflammatory skin condition.
The subcutaneously administered treatment is already indicated in the U.S. for conditions including atopic dermatitis and asthma, and the prurigo nodularis is the second skin condition the drug is greenlighted in the U.S.

The decision is based on data from two Phase 3 trials, PRIME and PRIME2, in which 60% and 58% of Dupixent-treated patients witnessed a clinically meaningful decline in itch at 24 weeks from the baseline compared to 18% and 20% for placebo.
âDupixent has the potential to transform the standard-of-care for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin,â remarked Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi (SNY).
During Q2 2022, Dupixent added â¬1.96B in sales for Sanofi (SNY) with ~43% YoY growth.