Jazz Pharmaceuticals has received a European Marketing Authorisation for Sunosi (solriamfetol) as a treatment for excessive daytime sleepiness in adults with narcolepsy and obstructive sleep apnoea.
The company announced that The European Commission has accepted the drug to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy as well as obstructive sleep apnoea (OSA), whose EDS has not been satisfactorily treated by primary OSA therapy.
The decision marks Sunosi as the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA, as well as the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy.
Jazz says that it is “excited” about the approval, as it can now offer the drug, which is “a daytime medicine that can provide sustained wakefulness throughout the day, compared to placebo, to patients living with excessive daytime sleepiness as a result of OSA or narcolepsy in Europe, where historically, treatment options have been very limited,” according to Bruce Cozadd, chairman and chief executive officer of the company.
The Marketing Authorisation Application (MAA) for Sunosi is based on data from four randomised placebo-controlled studies, which found that approximately 68-74% of people taking 75mg and around 78-90% of people taking 150mg reported improvement in their overall clinical condition.
The drug initially received US Food and Drug Administration (FDA) approval on March 20, 2019.
OSA is a highly prevalent disease affecting an estimated 1.5 million adults in the UK, and narcolepsy is a chronic, debilitating neurological disorder characterised by excessive daytime sleepiness. Narcolepsy is a rarer disease, with an estimated 30,000 people in the UK living with the condition.