The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of Jazz Pharmaceuticals’ (NASDAQ:JAZZ) solriamfetol to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure.
Solriamfetol is a dual-acting dopamine and norepinephrine reuptake inhibitor.
A final decision from the European Commission usually takes ~60 days.
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