Regeneron/Sanofi's Dupixent gets FDA priority review for skin disorder prurigo nodularis
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The U.S. Food and Drug Administration (FDA) granted priority review to Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi's (NASDAQ:SNY) Dupixent Medical's application seeking approval of Dupixent to treat prurigo nodularis (PN).
PN is a chronic skin disease that causes extreme itch and inflammatory skin rashes, lesions (nodules) on different parts of the body.

The FDA is expected to make a decision on the supplemental biologics license application (sBLA) by Sept. 30. Under priority review the FDA expects to take action on an application within six months, compared to 10 months under standard review.
The companies said that, if approved, Dupixent (dupilumab) would be the first medicine specifically indicated to treat prurigo nodularis in the U.S.
The companies noted that the sBLA is backed by data from two phase 3 trials, PRIME2 and PRIME.
Dupixent â which is approved for certain patients with atopic dermatitis, asthma, CRSwNP or eosinophilic esophagitis â generated $1.81B in sales Q1, according to Regeneron (REGN).
In March, Sanofi (SNY) had raised peak sales expectations of Dupixent to more than â¬13B.
SNY -3.68% to $53.12 premarket May 31