Sanofi, Regeneron Pharma bag USFDA nod for Kevzara to treat polymyalgia rheumatica

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. Patients often experience flares during tapering of, or relapse after discontinuation of corticosteroid (CS) treatment. Patients with PMR report difficulty in carrying out everyday functions such as getting out of bed, standing up from a chair, or lifting their arms. PMR generally affects people who are 50 years and older.

“Until now, people living with polymyalgia rheumatica have had limited treatment options for this serious rheumatic condition, which causes significant pain and discomfort,” said Bill Sibold, Executive Vice President, Head, Specialty Care at Sanofi. “The approval of Kevzara as the first and only biologic for polymyalgia rheumatica is a new option for patients and the healthcare professionals who treat them.”

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 ≥7.5 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 (n=60; 1 patient randomized but not treated) or placebo every two weeks along with a 52-week CS taper (n=58). At 52 weeks, the trial met its primary endpoint with 28% of Kevzara-treated patients achieving sustained remission compared to 10% for placebo (p=0.0193). 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.

A sensitivity analysis removing acute phase reactants (measures of ongoing inflammation) maintained significance (proportion difference for Kevzara vs. placebo: 18%; 95% confidence interval: 3.1 to 32.6) and confirmed the primary outcome. 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 placebo.

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