The US Food and Drug Administration (FDA) has approved tafenoquine (Arakoda) tablets manufactured by 60 Degrees Pharmaceuticals, LLC, for malaria prophylaxis in patients 18 years and older. This is the first new drug approved for the prevention of malaria in more than 18 years.
The approval comes on the heels of GlaxoSmithKline (GSK)’s tafenoquine (Krintafel) approval last month, which was the first single-dose medicine for the prevention of Plasmodium vivax malaria relapse in patients over the age of 16 years who are receiving antimalarial therapy. Krintafel is the first drug to be approved for the treatment of P vivax in over 60 years.
Both approvals were made under the contingency that GSK, and now 60 Degrees, complete post-marketing studies on the safety and efficacy of the drug formulations. Specifically, according to the FDA, GSK is required to "conduct an active pharmacovigilance study to evaluate safety, including hypersensitivity, neuropsychiatric, and hematologic adverse reactions, in patients taking Krintafel (tafenoquine) for the radical cure of P vivax malaria." Likewise, 60 Degrees is required to conduct "postmarketing studies to assess the drug's efficacy in children, older adults, and heavier individuals, and to answer questions about psychiatric safety and other adverse events," the Pink Sheet reports.
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