Chong Kun Dang said Thursday that its U.S. partner, Cara Therapeutics, has received approval from the Food and Drug Administration for uremic pruritus treatment, CR-845.

Chong Kun Dang participated in developing CR-845, branded as Korsuva, after gaining exclusive rights for domestic development and sales through an agreement made with Cara Therapeutics in 2012. CR-845 is an injection with a Kappa opioid receptor agonist used as the first-line monotherapy for moderate to severe uremic pruritus adult patients undergoing hemodialysis for chronic kidney disease.

It is the first and only first-in-class drug approved by the FDA in the uremic pruritus market.

Cara Therapeutics completed the multinational clinical trial of CR-845 in March 2020 and applied for approval to the FDA in December, and it was selected for priority review. In March, it applied for new drug approval to the European Medicines Agency (EMA).

CR-845 will make its debut in the global market next year through Cara Therapeutics and Swiss pharmaceutical company Vifor Pharma with the recent FDA approval. In Korea, Chong Kun Dang plans to apply for a license according to the procedure.

“CR-845 will be a new hope for uremic pruritus patients who have suffered from lack of an appropriate treatment, and we will quickly apply for regulatory approval and supply to the domestic market as soon as possible,” a Chong Kun Dang official said.

However, the official added, it is unclear whether Chong Kun Dang can apply within 2021 as the company will have to satisfy the procedures required by the Ministry of Food and Drug Safety, which is uncertain for now.