Treatment for Severe Malaria Receives Breakthrough Therapy Status

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

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

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.

For more information visit lajollapharmaceutical.com.

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This article originally appeared on MPR