We are pleased to share a community letter from Roche, announcing that the EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update to the European label for the risdiplam tablet.
We regret to inform that Roche has decided not to advance emugrobart (an investigational anti-myostatin antibody, also known as GYM329) into Phase III development for SMA, leading to the discontinuation of the MANATEE clinical study.
Today, Novartis announced that the company has received the FDA approval for Itvisma® (onasemnogene abeparvovec-brve), the intrathecal formulation of onasemnogene abeparvovec, to treat SMA in adult and pediatric patients 2 years of age and older with a confirmed mutation in SMN1.