From AI: Yes, clinical trials for Vascepa (icosapent ethyl) have been conducted in China, most notably a Phase III study for hypertriglyceridemia that was a requirement for drug approval. This trial was a multi-center study involving 373 patients and demonstrated that 4g/day of icosapent ethyl significantly lowered triglyceride levels in this population. Another trial was also conducted for cardiovascular risk reduction.
Hypertriglyceridemia trial:
A Phase III study was conducted in Mainland China to assess the safety and efficacy of icosapent ethyl (IPE) for patients with very high triglyceride levels.
The study showed that IPE at 4 g/day significantly lowered triglycerides compared to placebo, with an average reduction of 28.4% from baseline.
The trial was a multi-center, randomized, double-blind, placebo-controlled study.
Cardiovascular risk reduction trial:
A separate pivotal Phase III trial was also conducted in China to support approval for cardiovascular risk reduction.
Amarin Corp and its partner EddingPharm obtained regulatory approval for this indication in China based on these clinical trial results.
Approval and post-approval study:
Following the approval of Vascepa for cardiovascular risk reduction, a post-approval study is required by the Chinese regulatory authority to confirm the drug's efficacy.
EddingPharm continues to work with Amarin to make Vascepa accessible to patients in China.
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