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Expert Group Approves Safety, Efficacy of GSK’s Malaria Drug
Drugs Regulatory Affairs
Citing favorable clinical trial data, an FDA advisory committee voted Thursday in favor of the safety and efficacy of GlaxoSmithKline’s new drug application for tafenoquine indicated for radical cure and prevention of relapse of malaria.
The 13-0 vote in favor of efficacy concluded the meeting of the Antimicrobial Drugs Advisory Committee on the NDA for a proposed indication of the radical cure of plasmodium vivax malaria.
“I thought the efficacy data was very strong,” said committee member Dean Follmann, assistant director for biostatistics at the National Institute of Allergy and Infectious Diseases. “When we do a pooled analysis to compare it to primaquine we see they’re very similar.”