Jiangsu Vcare files NDA for Vicagrel Capsules with USFDA
Drug Approval

Jiangsu Vcare files NDA for Vicagrel Capsules with USFDA

  • By IPP Bureau | January 06, 2024

Jiangsu Vcare PharmaTech (Jiangsu Vcare) successfully submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Vicagrel capsule. This drug is indicated to treat a range of thrombotic cardiovascular and cerebrovascular diseases, including acute coronary syndrome, ischaemic stroke, and peripheral arterial disease. This filing marks a significant milestone as Jiangsu Vcare's first NDA submission from its innovative drug pipeline.

This NDA filing builds on continuous dialogues with the FDA and is supported by robust nonclinical data and clinical studies conducted in both China and US. Vicagrel, a novel oral P2Y12 receptor antagonist, represents Jiangsu Vcare's commitment to addressing unmet clinical needs with innovative approaches. Its mechanism of action involves the same active metabolite as clopidogrel that effectively inhibits platelet activation and aggregation, while addressing the issue of "clopidogrel resistance"

This NDA filing reflects more than ten years of persistent innovation and dedication by Jiangsu Vcare. Once approved, Vicagrel promises to offer a new treatment option for the estimated 27.6 million US patients with coronary heart disease and stroke.

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