Lotus Pharmaceutical (美時) announced on the 6th that VAZKEPA (Icosapent Ethyl) has received marketing authorization from the Singapore Health Sciences Authority (HSA). This marks the company's inaugural entry into the Southeast Asian market, representing a significant strategic milestone.

Clinical and Regulatory Context:

• Product Profile: VAZKEPA is the first prescription drug composed of highly purified icosapent ethyl (an EPA ethyl ester). It is indicated to reduce the risk of cardiovascular events in high-risk populations.
• Approved Indication: The HSA has approved VAZKEPA as an adjunct to maximally tolerated statin therapy. It is intended for adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease, or diabetes with two or more additional cardiovascular risk factors.
• Strategic Partnership: This launch further deepens the long-term exclusive partnership between Lotus and Amarin Corporation plc.

Market Significance: Statistics from 2024 indicate that cardiovascular disease (including heart disease and stroke) accounts for nearly one in three deaths in Singapore. General Manager Petar Vazharov emphasized that this approval showcases Lotus's commercialization capabilities in key Asian markets and its commitment to introducing innovative therapies to meet unmet medical needs.

Resource: 美時心血管藥 VAZKEPA 星國核准上市 取得東南亞首張藥證