SK Biopharmaceuticals gets a nod for a nodding-off drug

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SK Biopharmaceuticals gets a nod for a nodding-off drug

SK Biopharmaceuticals received final approval for the sale of a sleep disorder drug in Europe, the company said Tuesday.

Solriamfetol, which is sold under the Sunosi brand name, is marketed as an aid to improve wakefulness and reduce excessive daytime sleepiness (EDS) for adults with sleep disorders. The treatment targets people suffering from narcolepsy or severe obstructive sleep apnea (OSA).

According to the Korean bio company, Sunosi received sales approval from the European Medicines Agency - the European equivalent of the U.S. Food and Drug Administration (FDA).

The achievement comes a little more than a year since Jazz Pharmaceuticals, the global partner of SK Biopharmaceuticals, submitted the application for review.

According to the companies, Sunosi is the only new drug treating EDS to be approved by the European Commission. According to Jazz, nearly 16 million people in Europe may be affected by OSA and EDS to some extent, but the effectiveness of existing treatments has been limited.

A global leader in sleep medicine, Ireland-based Jazz Pharmaceuticals acquired rights for Sunosi in the United States and Europe in 2014 after SK Biopharmaceuticals completed the Phase 1 clinical trial. It started sales in the United States last year after receiving FDA approval.

Jazz plans to introduce Sunosi in Europe, starting in Germany, in mid-2020, moving on to France and Britain by early 2021.

As for SK Biopharmaceutical, which first discovered the drug, the company will receive royalties proportional to sales generated in the United States and Europe. The Korean biopharmaceutical company holds rights to sell solriamfetol in 12 Asian countries and is preparing to obtain sales authorizations in these markets.

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