CHMP backs Luxturna, Lilly's migraine mAb, antibiotic Vabomere
EMA's CHMP on Sept. 21 recommended several therapies for approval, including gene therapy Luxturna voretigene neparvovec, migraine mAb Emgality galcanezumab and antibiotic Vabomere meropenem/vaborbactam.
CHMP also confirmed its negative opinion for Exondys eteplirsen from Sarepta Therapeutics (NASDAQ:SRPT) for Duchenne muscular dystrophy.
Luxturna received CHMP's recommendation to treat adults and children with inherited retinal dystrophy caused by retinal pigment epithelium-specific protein 65kDa (RPE65) gene mutations. Novartis AG (NYSE:NVS; SIX:NOVN) has ex-U.S. rights to Luxturna