Roche (RHHBY.US) BTK inhibitor declared for listing

The Zhitong Finance App learned that on September 30, Roche (RHHBY.US) announced that the US FDA has accepted the new drug marketing application (NDA) for its non-covalent BTK inhibitor fenebrutinib and gave priority review to treat recurrent multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The press release indicates that, if approved, fenebrutinib will be the first BTK inhibitor for RMS and PPMS as well as the first high-efficacy oral treatment.

Fenebrutinib is a non-covalent BTK inhibitor under development that is highly effective, highly selective, and reversible. This design allows it to function throughout the body and can cross the blood-brain barrier into the central nervous system (CNS) to target chronic inflammation.

The marketing application was accepted based on fenebrutinib's comprehensive clinical trial data, including two RMS Indication Phase III studies fEnhance 1 and fEnhance 2, and a PPMS Indication Phase III study, FentrepID.

The fEnhance 1 and 2 studies showed that fenebrutinib significantly reduced the recurrence rate, as well as activity and chronic brain lesions compared to the standard treatment teriflomide.