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Genentech said the U.S. FDA accepted its New Drug Application for fenebrutinib under priority review for relapsing and primary progressive multiple sclerosis. The filing is based on three Phase III studies, including FENhance 1 and 2 and FENtrepid.
First BTK Inhibitor To Receive FDA Filing Acceptance For Both Forms Of MS - Reduced Relapses By 51% And 58% Versus Teriflunomide In Phase III Relapsing MS Trials - Slowed Disability Progression Versus Ocrevus In Phase III Primary Progressive MS Trial