FDA advisory committee endorses GSK’s malaria drug tafenoquine

The Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) has given a unanimous nod to GlaxoSmithKline’s (GSK) malaria drug, tafenoquine. This endorsement marks a significant milestone for the single-dose drug aimed at treating and preventing the relapse of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older.

Tafenoquine, an 8-aminoquinoline derivative developed by GSK in collaboration with Medicines for Malaria Venture (MMV), shows activity against all stages of the P. vivax lifecycle, including hypnozoites, which are dormant forms of the parasite responsible for relapses. It could become the first new medicine for this indication in over six decades if approved by the FDA, currently branded as Krintafel in the US.

The endorsement from AMDAC came after all 13 panel members affirmed the drug’s effectiveness, with 12 acknowledging its safety. This positive assessment is expected to play a crucial role in the FDA’s final decision-making process.

Pauline Williams, Head of Global Health R&D at GSK, emphasized the drug’s potential impact: “After extensive efforts to develop a new treatment for patients with P. vivax malaria, working in collaboration with Medicines for Malaria Venture, we welcome this endorsement.” David Reddy, CEO of MMV, also highlighted the significant step forward represented by AMDAC’s endorsement, pointing out the decade-long joint effort behind tafenoquine’s development.

The advisory committee’s support for tafenoquine is a promising development in the global fight against malaria, particularly for targeting the challenging P. vivax strain. This endorsement not only highlights the drug’s potential to provide a radical cure with just a single dose but also emphasizes the successful collaboration between GSK and MMV in pioneering significant advancements in malaria treatment.