Regeneron, Sanofi: Dupixent Approved In EU For Prurigo Nodularis

Regeneron Pharmaceuticals Inc. (REGN) and French drug major Sanofi (SNY) announced Thursday that the European Commission has expanded the marketing authorization for Dupixent (dupilumab) to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation.

Dupixent is an injection under the skin, i.e., subcutaneous injection, at different injection sites. Dupixent is administered at 300 mg every two weeks in the EU for adults with prurigo nodularis, following a loading dose. It is available as both a pre-filled pen and pre-filled syringe at the 300 mg dose.

With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat prurigo nodularis in Europe and the U.S. The drug is now approved to treat four chronic inflammatory diseases in the EU.

The latest EU approval was based on data from two Phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent in adults with uncontrolled prurigo nodularis compared to placebo.

As per the data, more than three times as many Dupixent patients experienced clinically meaningful itch reduction at 24 weeks compared to placebo.

George Yancopoulos, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent, said, "Dupixent is now approved for its second dermatological disease and fourth disease overall. We remain committed to further investigating this innovative medicine for diseases - such as chronic urticarias and chronic obstructive pulmonary disease - in which type 2 inflammation may play a role."

Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations.

Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan.

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