Benzinga | Feb 9, 2021 07:02AM EST

Amarin Announces Its Corporate Partner In China, Edding, Has Progressed VASCEPQA Into Commencement Of The Regulatory Review Processes In Mainland China And Hong Kong

Amarin Corporation plc (NASDAQ:AMRN) today announced that its corporate partner in China, Edding, has progressed VASCEPA(r) (icosapent ethyl) into commencement of the regulatory review processes in Mainland China and Hong Kong.

In Mainland China, the Chinese National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for VASCEPA. Edding is seeking labeling based on the entirety of clinical data available for VASCEPA, including the previously announced successful results of the Phase 3 study conducted by Edding as well as studies conducted by Amarin. Edding currently anticipates receiving a decision in Mainland China near the end of 2021.

In Hong Kong, on a separate track, the Hong Kong Department of Health is evaluating VASCEPA based on current approvals in the United States and Canada. The review process in Hong Kong is anticipated to conclude near the end of 2021.

"We congratulate our partner, Edding, on the advancements made in the regulatory submission and review processes of VASCEPA in Mainland China and Hong Kong," stated Steven Ketchum, Ph.D., senior vice president and president, research & development and chief scientific officer, Amarin. "The progress made is important for our vision of offering the unique benefits of VASCEPA to at-risk patients throughout the world. We look forward to the potential of introducing, through Edding, this important treatment option in Mainland China and Hong Kong."

"We are very glad to know that the applications for drug approval of VASCEPA were formally accepted by the National Medical Products Administration (NMPA) in Mainland China and the Department of Health in Hong Kong," stated James He, chief medical officer, Edding. "Prevention and treatment of cardiovascular disease (CVD) is one of the major initiatives promoted by Health China 2030. However, few new CVD medications other than statins were launched in the market during the past several decades. In November 2020, Edding announced the positive, statistically significant top-line results of the Phase 3 clinical trial conducted in Mainland China. We will continue working with Amarin to bring this cross-era innovative drug into China to benefit Chinese patients."