FDA has accepted Genentech’s new drug application for fenebrutinib under priority review for relapsing multiple sclerosis and primary progressive multiple sclerosis. The investigational oral Bruton’s tyrosine kinase inhibitor is the first drug in its class to receive FDA filing acceptance for both forms of the disease.
The application is supported by three Phase 3 trials: FENhance 1 and FENhance 2 in relapsing MS, and FENtrepid in primary progressive MS.
In the two relapsing MS studies, fenebrutinib reduced annualized relapse rates by 51.1% and 58.5%, respectively, compared with teriflunomide over 96 weeks. The studies also showed reductions in active and chronic brain lesions. Measures of disability progression showed trends favoring fenebrutinib over teriflunomide.
FENtrepid compared fenebrutinib with Ocrevus, or ocrelizumab, in primary progressive MS. Fenebrutinib met the study’s primary endpoint of noninferiority in reducing disability progression. It numerically reduced the risk of confirmed disability progression over 12 weeks by 12% compared with Ocrevus, although the reported confidence interval included no difference between treatments.
Serious adverse events occurred in 9% of patients on fenebrutinib and 9% on teriflunomide in FENhance 1. The respective rates were 11% and 6% in FENhance 2. In FENtrepid, serious adverse events occurred in 19% of patients receiving fenebrutinib and 19% receiving Ocrevus. Liver enzyme elevations occurred more often with fenebrutinib than with Ocrevus in the primary progressive MS study.
Fenebrutinib is designed to cross the blood-brain barrier and target B cells and microglia. Genentech said its clinical program included more than 2,700 participants.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!