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

 
• By Sue Sutter

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.

Blood sample with malaria parasite positive
Amivas' injectable artesunate is approved for treatment of severe malaria. • Source: Shutterstock

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