FDA approval for Kevzara to treat polymyalgia rheumatica
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Kevzara (sarilumab) for the treatment of polymyalgia rheumatica (PMR), 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 (RA) in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.
The FDA approval for this additional indication for Kevzara is based on results from the SAPHYR Phase III 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.
The common adverse reactions occurring in greater than 5% of patients treated with Kevzara (n=59) were neutropenia (15%), leukopenia (7%), constipation (7%), rash pruritic (5%), myalgia (7%), fatigue (5%), and injection site pruritus (5%). Serious adverse reaction of neutropenia occurred in 2 patients (3%) in the Kevzara group compared to none in the placebo group (n=58). In both cases of neutropenia, the participants had a neutrophil count less than 500 per mm3 without any infections; neutropenia resolved following permanent discontinuation of study drug. The most common adverse reactions that resulted in permanent discontinuation of therapy with Kevzara were neutropenia occurring in 3 patients (5%) and infection in 3 separate patients (5%), including COVID-19 (n=1), intervertebral discitis (n=1), and pneumonia (n=1).
Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Kevzara gain access to the medicine and receive the support they may need. KevzaraConnect, a comprehensive and specialized program that provides support services to patients throughout every step of the treatment process, can help eligible patients who are uninsured, lack coverage, or need copay assistance. Additionally, KevzaraConnect offers support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process. For more information, please call 1-844-KevzaraCall: 1-844-Kevzara (1-844-538-9272) or visit www.Kevzara.com.
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