Amivas (US) LLC picked up seven years of orphan drug exclusivity with the US Food and Drug Administration’s nod for its malaria drug artesunate, but whether the company also will pocket a tropical disease priority review voucher remains to be seen.
Amivas’ Malaria Drug Approval Brings Orphan Exclusivity, But Priority Review Voucher Status Unclear
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.
