FDA Approves Kevzara® (Sarilumab) for Treating Polymyalgia Rheumatica (PMR)

FDA Approves Sarilumab (Kevzara®) for Treating Polymyalgia Rheumatica (PMR)

FDA Approves Kevzara® (Sarilumab) for Treating Polymyalgia Rheumatica (PMR)

Regeneron Pharmaceuticals, Inc. and Sanofi have received FDA approval for Kevzara® (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients who have not responded well to corticosteroids or cannot tolerate corticosteroid taper. The FDA previously approved Sarilumab for treating adults with moderately to severely active rheumatoid arthritis who did not respond well to one or more disease-modifying antirheumatic drugs.

Publish Date: 28-02-2023 Source: Regeneron Pharmaceuticals, Inc.

Polymyalgia rheumatica (PMR) is a prevalent inflammatory disorder of unknown origin that predominantly affects elderly individuals from Western countries. It is characterized by intense pain and stiffness involving the shoulders, proximal areas of the arms, neck, pelvic girdle, and proximal regions of the thighs. Patients with PMR commonly experience morning stiffness lasting more than 45 minutes and other non-specific symptoms like fatigue and malaise. Elevated acute phase reactants such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) are typical in PMR. The disease affects women two to three times more often than men and is often linked with giant cell arteritis (GCA), the most frequent vasculitis in elderly people in Western countries, which mainly affects the large and medium arteries, particularly the branches of the proximal aorta. Patients with PMR are typically over 50 years old and present with bilateral pain and stiffness in the shoulders, proximal aspects of the arms, neck, pelvic girdle, and thighs. The disease has an abrupt onset, usually within a few days. Morning stiffness lasts longer than 45 minutes in the affected areas, gradually improves throughout the day, and worsens after rest. Most individuals with polymyalgia rheumatica will receive treatment with oral corticosteroid medication.

In the United Kingdom, PMR had an overall incidence rate of 95.9 per 100,000, with the highest incidence occurring in older age groups and women.

However, the current Polymyalgia rheumatica treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (KPL-301, Sarilumab, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the PMR treatment. The key companies in the advanced development stage are Kiniksa Pharmaceuticals, Ltd., Regeneron Pharmaceuticals, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Polymyalgia Rheumatica (PMR) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2022 to 2032.

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