Jazz Pharma sleep disorder drug secures CHMP backing for treatment of excessive daytime sleepiness in Europe
pharmafile | November 18, 2019 | News story | Research and Development, Sales and Marketing | EMA, jazz pharma, narcolepsy, pharma, solriamfetol
Jazz Pharma’s solriamfetol has secured a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), as the advisory panel voted to recommend the drug’s approval for the treatment of excessive daytime sleepiness (EDS) in narcolepsy (with or without cataplexy) or obstructive sleep.
Specifically, the recommendation concerns adult patients whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).
Data from four placebo-controlled studies were submitted in support of the decision, illustrating solriamfetol’s effectiveness comparted to placebo.
“Excessive daytime sleepiness due to narcolepsy or OSA may have negative impacts on a person’s ability to function at work or at home, and in OSA patients EDS can still occur despite the compliant use of CPAP treatment for upper airway obstruction,” remarked Professor Jean-Louis Pépin, Director of INSERM unit 1042 and Head of the Sleep and Physiology Department at the University Hospital in France. “I am hopeful this positive CHMP opinion leads to this novel treatment option becoming available for people living with EDS as a result of narcolepsy or OSA.”
Dr Robert Iannone, Executive Vice President, Research and Development of Jazz Pharma, also commented: “Today’s positive CHMP opinion is an important milestone for people living with EDS associated with narcolepsy or OSA, which has been shown to negatively impact the lives of people living with these conditions. This milestone brings us one step closer to potentially providing a new treatment option for people living with these sleep disorders in Europe.”
Matt Fellows
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