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Amivas Bests La Jolla In Race For US Approval Of Antimalarial Artesunate

 
• By Sue Sutter

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.

Wrench.
US FDA approval of Amivas’ artesunate has thrown a wrench in La Jolla’s plans to come to market with the same drug • Source: Shutterstock

Amivas (US) LLC, an emerging infectious diseases drug company, quietly outmaneuvered La Jolla Pharmaceutical Co. to become the first to win US Food and Drug Administration approval of intravenous artesunate for the treatment of severe malaria.

The 26 May approval of Amivas’ antimalarial seemingly will have a two-fold

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