• 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.

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This article FDA Approves Regeneron-Sanofi's Sarilumab As First Biologic For Stiffness, Pain In Muscles originally appeared on Benzinga.com

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