Chong Kun Dang announced on August 26 that its U.S. partner, Cara Therapeutics, has received final approval from the US Food and Drug Administration (FDA) for 'CR-845' (KORSUVA™), a treatment for uremic pruritus.
In 2012, Chong Kun Dang signed a contract with Cara Therapeutics, a US bioventure company, for the exclusive domestic development and sale of 'CR-845' and has been participating in drug development.
CR-845 is an injection with a Kappa opioid receptor agonist mechanism that is used as the first-line monotherapy for moderate to severe uremic pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
It is the first and only first-in-class drug to receive FDA approval in the uremic pruritus market.
Kara Therapeutics completed the multinational clinical trial of CR-845 in March 2020 and applied for product approval to the FDA in December, and received approval for priority review.
In March, it also applied for new drug approval (NDA) to the European Medicines Agency (EMA).
With this FDA approval, CR-845 will be launched in the global market in 2022 through Cara Therapeutics and Swiss pharmaceutical company Vifor Pharma. In Korea, Chong Kun Dang plans to apply for product license according to the procedure.
“CR-845 will be a new hope for patients with uremic pruritus who have suffered from the lack of an appropriate treatment,” said a Chong Kun Dang offical. “We plan to expedite the approval process in Korea and supply it to the market as soon as possible.”
