FDA Approves Regeneron-Sanofi's Sarilumab As First Biologic For Stiffness, Pain In Muscles

Vandana Singh

March 1, 2023 at 12:28 PM·1 min read

The FDA approved Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) and Sanofi SA's (NASDAQ: SNY) Kevzara (sarilumab) for polymyalgia rheumatica (PMR), an inflammatory rheumatic disease,
The approval covers adult patients who have had an inadequate response to corticosteroids or cannot tolerate corticosteroid taper.
Kevzara is now approved to treat two chronic inflammatory disorders.
PMR often initially presents with pain and stiffness around the neck, shoulder, and hip area, and symptoms include fatigue, low-grade fever, and weight loss.
PMR generally affects people who are 50 years and older.
The FDA approval for this additional indication for Kevzara is based on results from the SAPHYR Phase 3 trial in patients with steroid-resistant active PMR.
At 52 weeks, the trial met its primary endpoint, with 28% of Kevzara-treated patients achieving sustained remission compared to 10% for placebo.
In addition, an analysis of a secondary endpoint showed that the median cumulative CS dose was 777 mg for Kevzara, compared to 2044 mg for the placebo.
Price Action: REGN shares are up 0.69% at $765.66, and SNY stock is up 0.73% at $47.19 on the last check Wednesday.