FDA accepts Genentech fenebrutinib NDA for relapsing and primary progressive multiple sclerosis under priority review
The FDA accepted Genentech’s fenebrutinib application for relapsing and primary progressive multiple sclerosis under priority review. Phase III trials showed relapse-rate reductions of 51.1% to 58.5% versus teriflunomide and a 12% numerical risk reduction in disability progression versus Ocrevus in PPMS.
1. FDA accepts application
The FDA accepted Genentech’s new drug application for fenebrutinib covering relapsing multiple sclerosis and primary progressive multiple sclerosis, granting priority review. The filing marks the first BTK inhibitor accepted for both forms of MS.
2. Trial results
In the Phase III FENhance trials, fenebrutinib cut relapse rates by 51.1% to 58.5% versus teriflunomide over 96 weeks. The Phase III FENtrepid trial met non-inferiority to Ocrevus in PPMS disability progression and showed a 12% numerical risk reduction.
