Regeneron and Sanofi’s Kevzara approved by FDA for polymyalgia rheumatica

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) "announced that the FDA has approved Kevzara, or sarilumab, for the treatment of polymyalgia rheumatica, an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. The FDA evaluated the Kevzara application for PMR under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Kevzara was previously approved for the treatment of moderately-to-severely active rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirhermatic drugs. The FDA approval for this additional indication for Kevzara is based on results from the SAPHYR Phase 3 randomized clinical trial in patients with steroid-resistant active PMR, who flared on greater than or equal to7.5 mg/day prednisone or equivalent during taper. In the trial, patients were randomized to receive either Kevzara 200 mg every two weeks along with a 14-week taper of CS or placebo every two weeks along with a 52-week CS taper. At 52 weeks, the trial met its primary endpoint with 28% of Kevzara-treated patients achieving sustained remission compared to 10% for placebo. Sustained remission was defined as being in disease remission by week 12, absence of disease flare, C-reactive protein normalization from weeks 12 to 52, and adherence to the CS taper protocol from weeks 12 to 52."