Tafenoquine Redux: 60 Degrees Pharma’s Malaria Drug Gets Its Turn At US FDA Panel
Executive Summary
Extended dosing required for prophylactic indication could raise more advisory committee concerns about safety than the one-time dose of GlaxoSmithKline’s formulation, which was recently approved for prevention of relapse.
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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.