Drugs

Roche Wins Priority Review for Multiple Sclerosis Drug

David McFarland

— 1 min read
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FDA has accepted for priority review a Roche NDA for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The submission is based on data from the Phase 3 FENhance 1 and 2 RMS studies and the Phase 3 FENtrepid PPMS study. “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,” the company says.

Roche says fenebrutinib is designed to act throughout the body and to cross the blood-brain barrier into the central nervous system to target both the acute inflammation that causes relapses and chronic inflammation that is believed to contribute to disability progression.

Roche says the NDA for fenebrutinib is supported by three positive Phase 3 studies:

  • The FENhance 1 and 2 RMS studies showed that fenebrutinib significantly reduced relapses and both active and chronic brain lesions compared with standard of care, teriflunomide.
  • The FENtrepid PPMS study showed fenebrutinib met its primary endpoint of non-inferiority compared with Ocrevus (ocrelizumab), the current standard of care and only approved medicine for PPMS, in reducing disability progression

“The overall rate of serious adverse events for fenebrutinib and teriflunomide, respectively, was 9% and 9% in FENhance 1 and 11% and 6% in FENhance 2,” Roche says. “The overall rate of serious adverse events in FENtrepid was 19% for fenebrutinib and 19% for Ocrevus. Liver enzyme elevations were comparable between the fenebrutinib and teriflunomide arms in the RMS studies and observed more often with fenebrutinib compared to Ocrevus in the PPMS study. While an imbalance in reported fatalities was observed across the three pivotal studies, the deaths occurred at different timepoints and had various causes.”

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