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[HEALTH] · United States, Switzerland · 2 sources

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Part of situation: FDA priority reviews for new medical therapies (2 clusters)

Roche's fenebrutinib receives FDA priority review for multiple sclerosis

multiple sclerosis BTK inhibitor fenebrutinib priority review clinical trials

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for fenebrutinib under priority review. Developed by Roche and Genentech, the investigational oral, noncovalent Bruton tyrosine kinase (BTK) inhibitor is intended for the treatment of both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

The application is supported by three Phase III clinical trials. In the FENhance 1 and 2 studies involving patients with RMS, fenebrutinib demonstrated a reduction in the annualized relapse rate by 51% and approximately 59% respectively when compared to teriflunomide over 96 weeks. The FENtrepid study, which focused on PPMS, compared the drug to ocrelizumab and met the study goal of non-inferiority, showing a numerical 12% greater slowing of disability progression.

If approved, fenebrutinib would be the first BTK inhibitor to receive filing acceptance for both indications and would represent the first oral therapy available for PPMS.

Entities

FDA · Fenebrutinib · Genentech · Roche

Sources

Roche: FDA akzeptiert Zulassungsantrag für MS-Mittel Fenebrutinib [www.cash.ch]
FDA Accepts Fenebrutinib NDA Under Priority Review for Relapsing and Primary Progressive MS | NeurologyLive - Clinical Neurology News and Neurology Expert Insights [www.neurologylive.com]