Shots:

• The approval is based on the two P-III trials i.e.- KALM-1- KALM-2 along with additional 32 clinical studies that evaluate Korsuva vs PBO in patients with a mod. to sev. pruritus associated with CKD who undergoes hemodialysis
• Results: patients achieved four-point improvement from baseline on a measure of severe itch (40% & 37%) vs (21% & 26%) & was generally well tolerated
• Korsuva (inj.) is a KOR agonist targeting PNS & is expected to launch in the US in Q1’22 with reimbursement in H1’22. The NDA has received the US FDA’s priority review and if approved- the therapy will provide an improvement in the safety or effectiveness to treat serious conditions

Click here  | Ref: GlobeNewswire | Image: Cara Therapeutics