Roche Holding Ltd (RHHBY.US) announced on September 30 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 would become the first BTK inhibitor for both RMS and PPMS, as well as 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 allows it to act systemically and to cross the blood-brain barrier to enter the central nervous system (CNS), targeting 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 fenebrutinib significantly reduced relapse rates, as well as active and chronic brain lesions, compared with the standard treatment teriflunomide.