The Food and Drug Administration (FDA) has granted an investigational treatment for severe malaria Breakthrough Therapy designation.

The treatment, LJPC-0118, is being developed by La Jolla Pharmaceutical Company. In a statement, the Company indicated that in 2 randomized controlled trials, LJPC-0118 demonstrated superiority to quinine in reducing mortality in patients with severe falciparum malaria infection. Based on these results, La Jolla plans to submit a New Drug Application with the Food and Drug Administration (FDA) in the fourth quarter of 2019.

“This designation is a key regulatory milestone and we look forward to working closely with the FDA to further develop LJPC-0118,” said George Tidmarsh, MD, PhD, and CEO of La Jolla

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Recently, the FDA approved 2 new therapies for malaria: Arakoda and Krintafel. Arakoda (tafenoquine; 60 Degrees) is approved for the prevention of malaria in patients aged ≥18 years. Krintafel (tafenoquine; GlaxoSmithKline) is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients ≥16 years old who are receiving appropriate antimalarial therapy for acute P. vivax infection, making it the first single-dose therapy for this indication.

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