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Regeneron and Sanofi Receive the US FDA’s Approval for Kevzara (sarilumab) to Treat Polymyalgia Rheumatica

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Regeneron and Sanofi Receive the US FDA’s Approval for Kevzara (sarilumab) to Treat Polymyalgia Rheumatica

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  • The US FDA has approved Kevzara, a human anti-IL-6Rα mAb for PMR who have had an inadequate response to CS or cannot tolerate CS taper
  • The approval was based on the P-III trial (SAPHYR) evaluating Kevzara (200mg, q2w) with a 14wk. CS taper vs PBO (q2w) with a 52wk. CS taper in a ratio (1:1) in 118 patients. The trial met its 1EPs i.e., sustained remission (28% vs 10%) @52wks. Results of a sensitivity analysis excl. CRP from the sustained remission definition was consistent with the primary analysis (31.7% vs 13.8%), the incidence of TEAEs (94.9% vs 84.5%)
  • The 2EPs showed the median cumulative CS dose was 777mg vs 2044mg. The companies launched the patient support program i.e., KevzaraConnect to provide access to patients for Kevzara treatment & offer support from nurses & other specialists

Ref: Globenewswire | Image: Regeneron 

Related News:- Sanofi and Regeneron's Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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