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GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced today that the Food and Drug Administration (FDA) has approved the single dose of Krintafel (tafenoquine) for radical treatment (relapse prevention ) Plasmodium vivax (P vivax) Malaria in persons over 16 years of age who are receiving appropriate antimalarial treatment for acute P. vivax infection.
P. Vivax malaria has a significant impact on public health and the economy, mainly in Southeast Asia, Southeast Asia, Latin America and the Horn of Africa. It is estimated that the disease causes about 8.5 million clinical infections each year.
The United States has about 1,700 cases of imported malaria each year.
Krintafel is an 8-aminoquinoline derivative having activity against all stages of the P. vivax life cycle, including hypnozoites.
Dr. Hal Barron, Scientific Director and President of Research and Development, GSK, said: "The approval of Krintafel single-dose, the first new treatment for Plasmodium vivax malaria for over 60 years, is an important milestone for people living with this type of cancer.
This FDA approval was based on the efficacy and safety data of a comprehensive P. vivax global clinical development program, designed in agreement with the FDA.
With the approval of Krintafel, the FDA has awarded GSK a good tropical disease review, designed to encourage the development of new drugs and biologics for the prevention and treatment of certain neglected tropical diseases affecting millions of people around the world.
The Plasmodium parasite is a complex organism whose life cycle extends to humans and mosquitoes. After an infected mosquito bite, the P. vivax parasite infects human blood and causes an acute malaria episode.
It also has the ability to remain dormant in the liver (in a form known as the hypnozoite) from which it reactivates periodically. cause relapses of P. vivax malaria.
Thus, a single infection with P. vivax can give rise to multiple episodes of malaria, in the absence of a new mosquito bite. These relapses can occur weeks, months or even years after the initial infection.
The dormant liver forms of the parasite can not be easily treated by most antimalarial treatments active against the blood stage parasite
. Primaquine is currently the only FDA approved drug that targets the dormant liver stage to prevent relapse. It must be taken for 14 days to be effective, a diet that is badociated with poor compliance.
The use of a drug targeting dormant liver forms of the parasite, co-administered with currently available antimalarials such as chloroquine or artemisinin-based combination therapies (ACTs) is known like a radical cure.
P. vivax malaria can manifest as fever, chills, vomiting, malaise, headache and muscle aches and, in some cases, can lead to severe malaria and be fatal.
Krintafel should not be administered: G6PD deficiency or untested in patients with G6PD deficiency
The use of Krintafel during pregnancy may cause haemolytic anemia in a fetus deficient in G6PD. Krintafel is not recommended during pregnancy.
Women with reproductive potential should avoid pregnancy or use effective contraception for 3 months after taking Krintafel
In addition, an infant deficient in G6PD may be at risk of hemolytic anemia. Krintafel through bad milk. The G6PD status of the infant should be checked before starting badfeeding.
Krintafel is contraindicated in women who are badfeeding when the infant has G6PD deficiency or the infant's G6PD status is unknown. A woman with a child with G6PD deficiency or if the infant's G6PD status is not known, should not badfeed for 3 months after the Krintafel dose.
About 37 percent of the cases of malaria in the United States occur in women, including 5-6% are pregnant at the time they are infected.
When a woman is infected with malaria during pregnancy, she runs an increased risk of maternal and fetal complications, according to the Centers for Disease Control and Prevention (CDC).
Therapeutic options for uncomplicated and uncomplicated P. falciparum and P. vivax malaria infections in pregnant women are threatened by the spread of resistance to mefloquine.
To address this need, the CDC has published strong evidence of safety and effectiveness. to use artemether-lumefantrine (AL, or Coartem) to treat malaria during the second and third trimesters of pregnancy.
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA. -1088 or www.fda.gov/medwatch.
GSK is a global science-based healthcare company. For more information please visit www.gsk.com
Medicines for Malaria Ventures (MMV) – MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development .
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