(Reuters) – Jazz Pharmaceuticals Plc’s treatment for a form of sleep disorder has been recommended for approval in Europe by a panel of the European Medicines Agency (EMA), the regulator said on Friday.
Solriamfetol, which will be branded as Sunosi, has been backed for the treatment of excessive sleepiness in adult patients with narcolepsy and obstructive sleep apnea (OSA), the EMA’s human medicines committee (CHMP) said https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-november-2019.
The drug was approved in the United States earlier this year and is part of the company’s attempts to reduce its reliance on its blockbuster narcolepsy drug, Xyrem, which faced a setback last year.
OSA is a potentially serious sleep disorder that can cause breathing to repeatedly stop and start, while narcolepsy is a chronic sleep disorder with overwhelming daytime drowsiness and sudden bouts of sleep.
While final approvals are done by the European Commission, it generally follows the panel’s recommendation and announces its decision within a couple of months.
(Reporting by Pushkala Aripaka in Bengaluru; Editing by Sriraj Kalluvila)