Cara and Vifor’s Korsuva (difelikefalin) Receive the US FDA’s Approval for the Treatment of Moderate-to-Severe Pruritus Due to CKD in Patients with Hemodialysis

August 25, 2021 Auto Bot regulatory 0

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 to­ read full press release/ article | Ref: GlobeNewswire | Image: Cara Therapeutics

The post Cara and Vifor’s Korsuva (difelikefalin) Receive the US FDA’s Approval for the Treatment of Moderate-to-Severe Pruritus Due to CKD in Patients with Hemodialysis first appeared on PharmaShots.