Replies to post #441160 on Amarin Corp Plc (AMRN)

[AMRNEPA]

additional data with some dates:
A Phase 3 clinical trial of Vascepa (icosapent ethyl) was conducted in China to support its regulatory approval in that country. This study, Protocol Number EDPC003R01, was a 12-week, multi-center, randomized, placebo-controlled, double-blind trial that investigated Vascepa as a treatment for patients with very high triglycerides (≥500 mg/dL).

Details of the China Clinical Trial
Objective: To assess the safety and effectiveness of icosapent ethyl in treating Chinese patients with extremely high triglyceride levels (5.6 to 22.6 mmol/L).
Sponsor/Partner: The trial was conducted by Amarin's commercial partner in China, EddingPharm (EDDING).
Design: A randomized, double-blind, placebo-controlled design across 49 Chinese institutions.
Results: The study met its primary efficacy endpoint, demonstrating positive, statistically significant results in lowering fasting triglyceride levels, with a safety profile similar to placebo.

Registration: The trial was registered on the Chinese clinical studies registry (www.chinadrugtrials.org.cn, ID CTR20160569) and later on ClinicalTrials.gov (NCT04756180).
Regulatory Approval
The results from this trial, which mirrored Amarin's global MARINE study, were used to support the New Drug Application (NDA) submission in China.
In May 2023, the National Medical Products Administration (NMPA) of China granted regulatory approval for Vascepa as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

In July 2024, the NMPA granted a further approval for the cardiovascular risk reduction (CVRR) indication, allowing its use as an adjunct to statin therapy for patients with high triglyceride levels and established cardiovascular disease or diabetes with other risk factors, based on the global REDUCE-IT trial data.

As a condition of the CVRR approval, the NMPA requested a post-approval study from EddingPharm to verify the efficacy in Chinese patients for the product's renewal five years post-approval.