April 24, 2024

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SK Biopharmaceuticals, the new drug development unit of South Korea’s telecom-to-energy conglomerate SK Group, announced on March 21 that it has received marketing approval from the US Food and Drug Administration for its narcolepsy drug Sunosi based on solriamfetol, a compound it discovered.

Sunosi is an investigational drug for treating narcolepsy, which is a debilitating neurological disorder characterized by excessive sleepiness. The drug can also be effective for patients with obstructive sleep apnea, which is characterized by pauses in breathing during sleep.

“Our innovative new drug has successfully received approval from the FDA,” said SK Biopharmaceuticals CEO Cho Chung-woo. “We hope Sunosi will become a new treatment option for patients with sleep disorders.”

Its partner Jazz Pharmaceuticals, which currently owns the rights to sell its drug in the US and European markets, aims to launch the product in the US market during the first half of this year. In November last year, Jazz Pharmaceuticals also applied for approval of European Medicines Agency for Sunosi.

SK Biopharmaceuticals currently owns rights to sell the narcolepsy drug in 12 Asian countries, including Korea, Japan and China.

Meanwhile, in November last year, it also applied to get FDA approval to commercialize its new epilepsy treatment candidate cenobamate to expand its presence in the US.

By Song Seung-hyun (ssh@heraldcorp.com)