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SK Biopharmaceuticals marks first FDA approval

SK Biopharmaceuticals announced on Thursday that the US Food and Drug Administration has approved Sunosi, a novel drug that aims to improve wakefulness in adult patients with excessive daytime sleepiness.

The drug was developed by Irish firm Jazz Pharmaceuticals using solriamfetol, a compound discovered by the South Korean firm.

Sunosi can alleviate narcolepsy, the inability to control the sleep-wake cycle, or obstructive sleep apnea, in which people suffer pauses in breathing, disturbing their sleep,  

(Public Domain Picture)
(Public Domain Picture)

The SK Group subsidiary has the rights to the drug in 12 Asian countries, including Korea, China and Japan.

This is the first US FDA approval of a novel drug which compound was discovered by SK Biopharmaceuticals. It iis the first Korean-originated drug that treats the central nervous system to be greenlighted by the US regulator.

In August 2011, following phase 1 clinical trials, SK Biopharmaceuticals licensed out the rights for solriamfetol to Aerial Biopharma in the US.

The compound was designated as an orphan drug at the FDA, meaning that the medical condition the drug would treat affects only a small portion of the population, that under normal circumstances the pharma industry would have little interest in developing without government support.

In January 2014 Jazz acquired solriamfetol’s global sales rights from Aerial Biopharma.

The phase 3 clinical trials were completed in June 2017, after which in December 2017 Jazz applied for FDA approval. The firm is also awaiting results from the European Medical Agency, where it submitted an application in November 2018.

Sunosi is expected to be commercially available in the US following the final scheduling decision by the US Drug Enforcement Administration, which is typically within 90 days of FDA approval.

SK Biopharmaceuticals is also awaiting the FDA’s decision on its application for epilepsy treatment drug Cenobamate submitted in November 2018.

By Lim Jeong-yeo (