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Approvals Rare Diseases Real-World Evidence

Amivas’ Malaria Drug Approval Brings Orphan Exclusivity, But Priority Review Voucher Status Unclear

  • Analysis

Executive Summary

Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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