FDA 'Breakthrough Therapy' designation for GSK's malaria drug tafenoquine; EU Cervarix news

22 December 2013

The US Food and Drug Administration has granted “Breakthrough Therapy” designation for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria, from UK pharma giant GlaxoSmithKline (LSE: GSK) and Medicines for Malaria Venture (MMV).

Tafenoquineis not yet approved or licensed for use anywhere in the world. Breakthrough Therapy designation is the newest of the FDA’s programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.

Clinical backing

The Breakthrough Therapy designation was granted based on the results from an international, multicenter, randomized Phase II clinical trial in more than 300 patients with uncomplicated P. vivax malaria. Headline results from this trial were presented at the American Society of Tropical Medicine and Hygiene Meeting in November, and detailed results published in The Lancet in December 2013. Plans are underway to start a Phase III study in 2014, said GSK.

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