FDA 'priority' approval for GSK malaria relapse drug

Following an advisory panel recommendation on July 6, the US Food and Drug Administration has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax)malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

The drug is being developed by UK pharma major GlaxoSmithKline (LSE: GSK) in collaboration with Medicines for Malaria Venture (MMV).

Dr Hal Barron, who became chief scientific officer and president of R&D at GSK in April this year, said: “Today’s approval of Krintafel,  the first new treatment for Plasmodium vivax malaria in over 60 years, is a significant milestone for people living with this type of relapsing malaria. Together with our partner, Medicines for Malaria Venture, we believe Krintafel will be an important medicine for patients with malaria and contribute to the ongoing effort to eradicate this disease.”