1. Scrip
  2. >>New Products

Cara Gets US Approval Of I.V. Korsuva, But Prospects Murky For Oral Version

 
• By Joseph Haas

The kappa opioid receptor agonist is not listed as a scheduled substance and labeling meets expectations. Cara and partner Vifor plan to launch the product in early 2022.

Dialysis center Korsuva approval
Cara and Vifor hope to bring Korsuva to market in early 2022 • Source: Alamy

Cara Therapeutics, Inc. and Vifor Pharma Group ’s Korsuva (difelikefalin) reached the end of the long path to approval on 23 August, as the intravenous kappa opioid receptor agonist was cleared by the US Food and Drug Administration to treat pruritus in chronic kidney disease patients on dialysis. Cara’s prospects for an oral version of the drug remain unclear, however, given mixed data reported earlier this year in atopic dermatitis.

For more than a decade, Connecticut-based Cara has built its whole business strategy around difelikefalin, with a particular emphasis on the oral formulation, as it licensed US and EU commercial rights to the I.V. product to Vifor and the joint venture Vifor Fresenius Medical Care Renal Pharma Ltd. in separate deals in 2018 and 2020

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Thirteen Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Merck KGaA Seals SpringWorks Buy

 
• By Kevin Grogan

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

More from Scrip

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 
• By Sushmita Panda

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 
• By Sushmita Panda

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.