UPDATE : Monday, July 13, 2020
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SK Biopharma’s US partner gets EMA nod for sleepiness treatment
  • By Lee Han-soo
  • Published 2020.01.21 14:22
  • Updated 2020.01.21 14:22
  • comments 0

Jazz Pharmaceuticals, SK Biopharmaceutical’s U.S. partner, has received sales approval from the European Medicine Agency (EMA) for Sunosi (Ingredient: solriamfetol), a treatment to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

EMA approved Sunosi as a treatment for adult sleep apnea patients with or without elastic seizures and for adult sleep apnea patients, who have not had satisfactory results in daytime sleepiness treatment even with primary obstructive sleep apnea treatment such as continuous positive airway pressure.

SK Biopharmaceutical discovered Sunosi and completed its phase 1 clinical trial before licensing out the substance to Aerial BioPharma in 2011. Afterward, Jazz Pharmaceuticals took over the global commercialization rights, including the U.S. and Europe, to complete the phase 3 clinical trials for the drug.

Jazz Pharma has launched the drug in the U.S. after receiving sales approval from the U.S. Food and Drug Administration for Sunosi in March last year.

In Europe, the company submitted a new drug marketing application (NDA) to the EMA in November 2018 and received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in November of last year.

With the EMA approval, Jazz Pharma plans to launch Sunosi starting in Germany in mid-2020 and then expand to France and the U.K. by early 2021,

The company also plans to conduct additional clinical trials in patients with daytime sleepiness due to major depressive disorder (MDD) to expand indications for the drug.

“We will continue to launch innovative new drugs through our in-house development and our excellent with Jazz Pharmaceuticals to improve the quality of life of patients,” SK Biopharmaceuticals CEO Cho Jeong-woo said.


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