FDA OKs Regeneron-Sanofi's Sarilumab As First Biologic For Stiffness, Pain In Muscles
- The FDA approved Regeneron Pharmaceuticals Inc's and Sanofi SA's 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.
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