SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, affiliated to Swiss drug major Roche Holding AG (RHHBY, RO.SW, ROG.SW) announced Wednesday that the U.S. Food and Drug Administration has accepted its New Drug Application or NDA under priority review for fenebrutinib in both relapsing and primary progressive multiple sclerosis, a chronic disease.
Fenebrutinib is an investigational non-covalent Bruton's tyrosine kinase or BTK inhibitor for the treatment of relapsing multiple sclerosis or RMS and primary progressive multiple sclerosis or PPMS.
Genentech noted that Fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both RMS and PPMS.
The filing acceptance is based on data from the comprehensive clinical program, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study.
According to the firm, Fenebrutinib is designed to address two drivers of MS, such as acute inflammation causing relapses and chronic brain inflammation driving disability progression.
The company noted that Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability.
If approved, fenebrutinib is expected to become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS.
Levi Garraway, chief medical officer and head of Global Product Development, stated, 'Three Phase III studies have demonstrated the potential for fenebrutinib to address both relapsing and progressive disease, thereby bringing us closer to an oral treatment that could make a meaningful difference across the MS spectrum.'
For More Such Health News, visit rttnews.com
Copyright(c) 2026 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2026 AFX News
