A new malaria drug that could help eradicate that disease has been approved by the Food and Drug Administration and will be considered for the Defense Department’s use.
Two different forms of the new drug Tafenoquine have been approved by the FDA for the prevention and treatment of malaria, which is the top infectious disease threat to military members deployed overseas, according to the Army Medical Materiel Development Activity. Malaria is transmitted through the bite of an infected mosquito.
Despite the use of preventive drugs and personal protective equipment, malaria remains a significant threat to the warfighter, officials said
The new Tafenoquine drugs are:
- Krintafel, a single dose treatment for the cure of the Plasmodium vivax form of malaria, approved July 20. The current drug must be taken for 14 days to be effective.
- Arakoda is a preventive malaria drug taken for the three days before travel, then weekly, during time in areas known to have mosquitoes infected with the malaria parasite. It was approved Aug. 8. It protects against all malaria, including Plasmodium falciparum, which is a serious, deadly form of malaria.
Tafenoquine has the potential to help eradicate malaria, according to officials with the Army Medical Materiel Development Activity. It is “highly effective” in the prevention of malaria, because it attacks the malaria parasite during multiple stages of its life cycle. No other FDA-approved anti-malaria drug can provide this protection, so it’s a substantial improvement over current therapies, officials said. It kills parasites in both the blood and the liver. Most of the currently used drugs don’t kill the liver form of the parasite, which can sleep in the liver and bring a relapse of malaria months or years later.
Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research, and is the first new FDA-approved anti-malaria drug in more than 18 years.
The malaria drugs that are currently used primarily are those that require daily doses, including doses afterward for further protection. Instead, Tafenoquine (Arakoda) requires weekly doses for prevention, and a single dose following return from an area with malaria.
A big advantage to Arakoda over current drugs is the weekly dose, said Army Col. Andrew Wiesen, director of preventive medicine in the DoD office of health readiness policy and oversight. For the drugs that are taken daily, within a required tight time frame, "if you miss a dose, you could expose yourself to risk. We like these drugs because of their infrequent dosing interval.
“Primarily right now, it will be most important for troops deploying to specific areas where this kind of malaria, falciparum malaria, exists, and where there’s known resistance to other types of prophylactic agents that we could use instead.”
A spokeswoman for 60 Degrees Pharmaceuticals said officials expect Arakoda will be available in the first quarter of 2019. A spokesman for GlaxoSmithKline pharmaceutical company said officials “plan to make Krintafel available in the U.S. as soon as possible.”
Officials are focused on adding it to the tri-service formulary, which is a list of brand name and generic drugs and supplies that Tricare covers; and evaluating it for use as a force protection medication, according to Defense Health Affairs officials.
Once Tafenoquine is available commercially, it would be up to the individual health care provider as to whether to prescribe it. In some cases it could be used as an alternative when the patient can’t take other malaria drugs for some reason. If it’s added to the repertoire of drugs for force protection medication as a potential malaria drug, the exact choice could also be up to the command or individual health care providers.
The FDA approval came after more than 25 clinical trials involving more than 3,000 trial subjects, with the Army Medical Materiel Development Activity and 60 Degrees Pharmaceuticals.
There have been a variety of issues with certain antimalarial drugs in the past, including mefloquine, also known as Lariam, once widely used by the military. In 2013, the Defense Department designated mefloquine as the antimalarial drug of last resort after the FDA required a black box warning on its label, noting it can cause permanent psychiatric and neurological side effects.
According to 60P, tafenoquine should not be given to people with a history of psychotic disorders or current psychotic symptoms. Testing for G6PD deficiency must be performed before tafenoquine, because of the risk of hemolytic anemia.
60P has committed to do safety surveillance studies to continue to gather data.