Vifor Pharma
Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™ injection in hemodialysis patients with moderate-to-severe pruritus
Monday, March 8, 2021 1:10PM IST (7:40AM GMT)
St. Gallen, Switzerland & Stamford, Conn., United States:
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of 23 August 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
Regulatory News:
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that
Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA injection in hemodialysis patients with moderate-to-severe pruritus
If approved, KORSUVA injection would be first therapy for treatment of pruritus in hemodialysis patients
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for .
Cara Therapeutics, Inc.March 8, 2021 GMT
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
STAMFORD, Conn, and ST. GALLEN, Switzerland, March 08, 2021 (GLOBE NEWSWIRE) Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the
Vifor Pharma delivers strong full year results 2020 with an EBITDA of 576 million Swiss Francs representing over 29% growth1
DEMAND INFLUENCED BY LOCKDOWN MEASURES
Global in-market sales: CHF 1,005 million, up 0.1% and 49.5% share in the i.v. iron segment of the iron market
4 by value in 2020
5
Net sales of CHF 552.2 million, a decrease of 1.6%, an increase of 3.0% at CER.
Improvements in Q3 in line with the easing of COVID-19 restrictions and better patient access to infusions, followed by a slowdown towards year end as many countries started reintroducing restrictions. Overall utilization of i.v. iron has been highly correlated with intensity of lockdown measures, with recovery to pre-COVID-19 growth levels expected once COVID-19 restrictions are lifted.
Vifor Pharma delivers strong full year results 2020 with an EBITDA of 576 million Swiss Francs representing over 29% growth1 cadillacnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from cadillacnews.com Daily Mail and Mail on Sunday newspapers.