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
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