Krintafel Approved to Treat Malaria
July 20, 2018 – The U.S. FDA has approved Krintafel (tafenoquine), developed by GlaxoSmithKline and Medicines for Malaria Venture (MMV), to prevent relapse of patients who are at least 16 years old and receiving appropriate antimalarial treatment for acute Plasmodium vivax infection.
Krintafel is the first new medication in over 60 years to receive FDA approval to treat malaria caused by P. vivax. A parasitic protozoan organism, P. vivax is one of five different species known to be responsible for malaria in humans. The organism accounts for an estimated 8.5 million clinical infections each year, with most cases occurring in Asia, Latin America, and parts of Africa. It can lie hidden in the liver for years following initial infection, and cause multiple relapse episodes of malaria. Although not considered the most severe form of malaria, P. vivax infection can still result in serious and sometimes fatal complications.
Approved under a tropical disease priority review, Krintafel targets the hidden form of P. vivax, known as hypnozoites, and eliminates them to prevent relapse episodes. Standard antimalarial treatment is still required. Recommended dosing with Krintafel is 300mg given just once, on the first or second day of treatment with appropriate antimalarial therapy. Patients should be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to treatment with Krintafel, due to potential for hemolytic anemia. The drug should not be used by women who are pregnant, or who are nursing infants who have G6PD deficiency.
Launch and pricing plans have not yet been announced.