La Jolla’s formulation appears blocked by Amivas’ seven-year orphan exclusivity, and the company also will miss out on chance for a tropical disease priority review voucher;  Amivas worked with the US Army to bring the severe malaria treatment through final stages of development and regulatory review.

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.

GlaxoSmithKline has proposed to market and manufacture antimalarial Krintafel in India and an expert panel has sought additional information to progress a review of these plans. GSK and partner MMV aim to ensure that the cost of the therapy does not impede access.

The latest drug development news and highlights from our US FDA Performance Tracker.