Chong Kun Dang's New Drug for Uremic Pruritus with Exclusive Sales Rights Approved by US FDA

[Asia Economy Reporter Seo So-jung] Chong Kun Dang Pharmaceutical Corp. (CEO Kim Young-joo) announced on the 26th that CR-845 (brand name Kosuva), a uremic pruritus treatment developed by the U.S. company Cara Therapeutics, for which it holds exclusive domestic sales rights, has received final approval from the U.S. Food and Drug Administration (FDA).

Chong Kun Dang signed an exclusive domestic development and sales agreement for CR-845 with the U.S. biotech venture company Cara Therapeutics in 2012 and has participated in the drug's development.

CR-845 is an injectable kappa opioid receptor agonist used as a first-line monotherapy for moderate to severe uremic pruritus in adult patients undergoing hemodialysis due to chronic kidney disease. It is the first and only FDA-approved drug in the uremic pruritus market.

Cara Therapeutics completed multinational clinical trials for CR-845 in March 2020 and submitted a new drug application (NDA) to the FDA in December, receiving priority review status. In March, it also submitted an NDA to the European Medicines Agency (EMA).

With this FDA approval, CR-845 is expected to be launched globally in 2022 through Cara Therapeutics and the Swiss pharmaceutical company Vifor Pharma. Domestically, Chong Kun Dang plans to apply for product approval following the necessary procedures.

A representative from Chong Kun Dang stated, "The approval of CR-845 will bring new hope to patients suffering from uremic pruritus who had no appropriate treatment options," adding, "We plan to expedite the approval process domestically to supply the market as soon as possible."

This content was produced with the assistance of AI translation services.