The FDA has slammed the brakes on Roche’s (OTCQX:RHHBY) Genentech subsidiary’s development program for the drug fenebrutinib, a potential treatment for multiple sclerosis.
Genentech revealed that the FDA took action after two cases of elevated liver enzymes and bilirubin, which indicated drug-induced liver injury, occurred during a Phase 3 study of the drug in relapsing MS. The elevated levels returned to normal after the drug was withdrawn.
Consequently, the Phase 3 trial FENhance I has been halted in the US, but enrollment will continue in other countries. Meanwhile, the two other Phase 3 trials, FENhance II and FENhance III, are fully enrolled, as per a Genentech statement.
The company announced that patients receiving the drug for more than 70 days will persist with the therapy, while a “small number” of US participants will discontinue it. Genentech emphasized its unwavering dedication to evaluating the drug for relapsing MS and primary progressive MS.