Roche (RHHBY.US) BTK inhibitor submitted for marketing approval

On September 30, Roche (RHHBY.US) announced that the U.S. FDA has accepted its New Drug Application (NDA) for the 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 for RMS and PPMS and the first high-efficacy oral treatment option. Fenebrutinib is an investigational non-covalent BTK inhibitor that is highly potent, highly selective, and reversible. This design enables it to act throughout the body and to cross the blood-brain barrier into the central nervous system (CNS) to target chronic inflammation. The acceptance of this marketing application is based on comprehensive clinical trial data for fenebrutinib, including two Phase III studies in RMS, FENhance 1 and FENhance 2, and one Phase III study in PPMS, FENtrepid. The FENhance 1 and 2 studies showed that, compared with the standard treatment teriflunomide, fenebrutinib significantly reduced relapse rates, as well as active and chronic brain lesions.