A US FDA advisory committee endorsed the efficacy and safety of [60 Degrees Pharmaceuticals LLC]’s Arakoda (tafenoquine) for malaria prevention in adults but is counting on postmarketing studies to provide clarity on questions left unanswered by the “patchwork” of small trials supporting the application.
60 Degrees’ Arakoda Gets US FDA Panel Nod For Malaria Prophylaxis
Postmarketing studies are needed to assess tafenoquine’s efficacy in children, older adults and heavier individuals, and to answer questions about psychiatric safety and other adverse events, advisory committee says.

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