Amarin Partner EddingPharm Receives Regulatory Approval for Vascepa® (Icosapent Ethyl) in Mainland China
DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA). NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).
- DUBLIN, Ireland and BRIDGEWATER, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that its commercial partner in China, EddingPharm (EDDING), has received regulatory approval for VASCEPA® (icosapent ethyl) from China’s National Medical Products Administration (NMPA).
- NMPA granted approval for VASCEPA as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (≥500 mg/dL).
- Following regulatory approval, EDDING is now focusing on National Reimbursement Drug Listing (NRDL) and preparing for commercial launch in China, expected by year-end, as well as on advancing regulatory submission and review for an additional indication in cardiovascular risk reduction (CVRR).
- Following the NMPA approval for this indication, Amarin is now entitled to receive a regulatory milestone payment of $5 million.