What's Happening?
Genentech has announced promising results from its Phase III FENtrepid study, which evaluated the efficacy of fenebrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, in treating primary progressive multiple sclerosis (PPMS). The study demonstrated that fenebrutinib met its primary endpoint of non-inferiority compared to Ocrevus, the current standard of care, by reducing disability progression. Fenebrutinib showed a 12% reduction in the risk of disability progression and a notable improvement in upper limb function. Regulatory submission for fenebrutinib in both PPMS and relapsing multiple sclerosis is planned following further study results.
Why It's Important?
Fenebrutinib represents a potential breakthrough in the treatment of PPMS, a condition with limited
therapeutic options. The drug's ability to reduce disability progression and improve upper limb function could significantly enhance the quality of life for patients. This development is crucial as it offers a new oral treatment option that acts directly in the brain, targeting progressive biology. The success of fenebrutinib could lead to its approval and availability, providing a much-needed alternative to existing therapies and potentially setting a new standard in MS treatment.
What's Next?
Genentech plans to advance its regulatory submission for fenebrutinib following the readout of its second pivotal RMS study, FENhance 1. The company is also preparing to submit data from all Phase III trials to regulatory authorities. If approved, fenebrutinib could become a first-in-class treatment for PPMS, offering a new option for patients and potentially reshaping the MS treatment landscape.
