Roche (RHHBY.US) BTK inhibitor submitted for listing

According to Jinse Finance, on September 30, Roche (RHHBY.US) announced that the U.S. FDA has accepted the New Drug Application (NDA) for its non-covalent BTK inhibitor fenebrutinib and granted it priority review, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). According to the press release, if approved, fenebrutinib will become the first BTK inhibitor indicated for both RMS and PPMS, as well as the first highly effective oral treatment option.

Fenebrutinib is an investigational non-covalent BTK inhibitor with high efficacy, high selectivity, and reversibility. This design allows it to exert effects throughout the body and to cross the blood-brain barrier into the central nervous system (CNS), offering targeted therapy for chronic inflammation.

The acceptance of this NDA is based on comprehensive clinical trial data for fenebrutinib, including two phase III studies for RMS indications, FENhance 1 and FENhance 2, as well as one phase III study for PPMS indications, FENtrepid.

The FENhance 1 and 2 studies showed that compared to the standard treatment drug teriflunomide, fenebrutinib significantly reduced relapse rates, as well as active and chronic brain lesions.