The U.S. Food and Drug Administration (FDA) has agreed to review an application from Roche seeking approval of its BTK inhibitor fenebrutinib as a treatment for relapsing forms of both multiple sclerosis (MS) and primary progressive MS (PPMS). Further, the FDA granted the application priority review, under…
Fenebrutinib
Fenebrutinib, Genentech’s investigational BTK inhibitor, was found to significantly reduce relapse rates compared with the approved therapy Aubagio (teriflunomide) in two Phase 3 clinical trials involving people with relapsing forms of multiple sclerosis (MS). Positive top-line results from one of those trials, FENhance 2 (NCT04586023),…
The investigational BTK inhibitor fenebrutinib was as effective as the approved therapy Ocrevus (ocrelizumab) at reducing the risk of disability progression in people with primary progressive multiple sclerosis (PPMS), meeting the main goal of a Phase 3 trial. According to fenebrutinib’s developer, Genentech, the therapy is the…
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