Business
Cara Therapeutics Reports Second Quarter 2021 Financial Results
– New Drug Application (NDA) Filing for KORSUVA™ Injection in CKD-aP under Priority Review by U.S. Food and Drug Administration (FDA); PDUFA Target Action
About this update from Tvardi Therapeutics, Inc.
[{"type":"text","content":"– New Drug Application (NDA) Filing for KORSUVA™ Injection in CKD-aP under Priority Review by U.S. Food and Drug Administration (FDA); PDUFA Target Action Date August 23, 2021 – – Conference call today at 4:30 p.m. ET – STAMFORD, Conn., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced financial results and operational highlights for the second quarter ended June 30, 2021. “Having completed the late-cycle review of our NDA for our lead asset KORSUVA™ Injection with the FDA during the second quarter of the year, we remain on track for an expected Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021 and continue to be focused, along with our commercial partner, Vifor Pharma, on preparation for the U.S. launch of KORSUVA Injection in the second half of 2021, if approved,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We also continue to make good progress in our Oral KORSUVA programs across a range of patient populations where pruritus treatment remains a significant unmet need and, pending the outcome of our scheduled End-of-Phase 2 meeting with the FDA, aim to initiate our first Oral KORSUVA Phase 3 program in mild-to-moderate atopic dermatitis patients by year-end of 2021.” Second Quarter and Recent Developments: KORSUVA Injection: Chronic Kidney Disease-Associated Pruritus (CKD-aP): Hemodialysis In February 2021, the FDA accepted the filing of the NDA for KORSUVA Injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. Shortly after this decision, the FDA granted Priority Review for the NDA filing of KORSUVA Injection in March 2021 with an expected PDUFA target action date of August 23, 2021. Following these decisions, the potential FDA approval and subsequent U.S. commercial launch of KORSUVA Injection could take place in the second half of 2021. If approved, KORSUVA Injection would be the first treatment for CKD-aP in hemodialysis patients. In March 2021, the Company and Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) announced that the European Medicines Agency (EMA) accepted to review the M...