EDDING today announced that the applications for drug approval of VASCEPA® have been formally accepted by National Medical Products Administration in Mainland China.
Edding plans to seek possible indications in Mainland China based on VASCEPA®'s existing clinical data in China and abroad, including the previously announced successful results of the Phase III study conducted by Edding in Mainland as well as other studies conducted by Amarin abroad. Edding currently anticipates receiving decision by end of 2021 in Mainland China.
“We are very glad to know that the applications for drug approval of VASCEPA® were formally accepted by National Medical Products Administration (NMPA) in Mainland China,” stated James He, chief medical officer, Edding. “Cardiovascular Disease (CVD) is the heaviest disease burden and the leading cause of death in China. Prevention and treatment of CVD is one of the major initiatives promoted by Health China 2030. However, few new CVD medications other than statin were launched in the market during the past decades. Huge amount of unmet need remains. VASCEPA® can effectively reduce major adverse cardiovascular events and solve the urgent clinical demand for safe and effective products in the field of cardiovascular treatment. In November 2020, Edding announced the positive, statistically significant top-line results of the Phase III clinical trial conducted in Mainland. Furthermore VASCEPA® was also obtained “pre license supply” qualification in Hainan Pilot Zone last month as the first innovative CVD drug with urgent clinical needs. We will continue working with Amarin to bring this cross-era innovative drug into China and benefit Chinese patients.”
“We congratulate our partner, Edding, on the advancements made in the regulatory submission and review processes of VASCEPA® in Mainland China,” 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.”
About REDUCE-IT®
REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology. The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018. Compared to placebo, administration of VASCEPA 4 g/d demonstrated 25% risk reduction in major adverse cardiovascular events (MACE). The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019. These and other publications can be found in the R&D section on Amarin’s website at www.amarincorp.com.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA® (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. FDA comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA® was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. In December 2019, the new cardiovascular risk indication for VASCEPA® was approved by the FDA and it was launched as the first and only drug for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. Since launch, VASCEPA® has been prescribed over ten million times. VASCEPA® is covered by most major medical insurance plans. In addition to the United States, VASCEPA® is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, approval is anticipated in April 2021 following the January 29, 2021 favorably opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA®.
i Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.
ii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.
iii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Reduction in first and total ischemic events with icosapent ethyl across baseline triglyceride tertiles. J Am Coll Cardiol. 2019;74:1159-1161.