FDA Approves Regeneron Sanofi Treatment For Rare Autoimmune Skin Disorder

The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals Inc. REGN and Sanofi SA’s SNY Dupixent (dupilumab) for adult patients with bullous pemphigoid (BP), a rare, chronic autoimmune skin disorder.

BP primarily affects elderly patients and is characterized by intense itch, painful blisters and lesions, and skin reddening. It can be chronic and relapsing with underlying type 2 inflammation.

The blisters and rash can form over much of the body and cause the skin to bleed and break down, making patients more prone to infection.

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The FDA approval is based on data from the pivotal ADEPT Phase 2/3 trial that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP.

Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS).

During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained.

The FDA-approved results at 36 weeks in the label for Dupixent compared to placebo are:

• 18.3% of patients experienced sustained disease remission compared to 6.1%, the primary endpoint.
• 38.3% of patients achieved clinically meaningful itch reduction compared to 10.5%.
• The median cumulative OCS dose was 2.8 grams compared to 4.1 grams.

In this elderly population, the most common adverse events (≥2%) more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis.

Additionally, one acute generalized exanthematous pustulosis was reported in 1 patient treated with Dupixent and zero treated with placebo.

In April, the FDA approved Dupixent for adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

Price Action: REGN stock closed at $513.58 on Wednesday. SNY stock is up 1.45% at $48.31 during the premarket session at the last check on Friday.

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