Silver Spring, Maryland, USA : The US Food and Drug Administration (FDA) has approved tafenoquine (Arakoda) tablets manufactured by 60 Degrees Pharmaceuticals, LLC, for malaria prophylaxis in patients 18 years and older. This is the first new drug approved for the prevention of malaria in more than 18 years.
The approval comes on the heels of GlaxoSmithKline (GSK)’s tafenoquine (Krintafel) approval last month, which was the first single-dose medicine for the prevention of Plasmodium vivax malaria relapse in patients over the age of 16 years who are receiving antimalarial therapy. Krintafel is the first drug to be approved for the treatment of P vivax in over 60 years.
Both approvals were made under the contingency that GSK, and now 60 Degrees, complete post-marketing studies on the safety and efficacy of the drug formulations. Specifically, according to the FDA, GSK is required to “conduct an active pharmacovigilance study to evaluate safety, including hypersensitivity, neuropsychiatric, and hematologic adverse reactions, in patients taking Krintafel (tafenoquine) for the radical cure of P vivax malaria.” Likewise, 60 Degrees is required to conduct “postmarketing studies to assess the drug’s efficacy in children, older adults, and heavier individuals, and to answer questions about psychiatric safety and other adverse events,” the Pink Sheet reports.
Additional studies are required in part because of small clinical trial size, the fact that many of the trials were conducted more than a decade ago, and the neurotoxic and psychiatric adverse events seen in deployed military personnel who had been administered the drug in clinical development studies that were not seen in nondeployed individuals, according to the Pink Sheet.
“We have worked closely with the US Army as their commercial partners to bring Arakoda to the US market,” Geoffrey Dow, PhD, CEO of 60 Degrees shared in a statement. “Arakoda provides effective protection against both of the major types of malaria (P vivax and P falciparum), killing the parasites in both the blood and liver. This provides the travel medicine community the option to prescribe an anti-malarial which provides protection in a large spectrum of malaria hot zones while utilizing what is considered by many physicians to be a more compliant dosing regimen. Arakoda is a significant addition to the armamentarium for the prevention of malaria.”
A spokesperson for 60 Degrees advised Contagion® that the added benefits of Arakoda over drugs that are currently available include that Arakoda, “provides an alternative as existing antimalarials are becoming resistant while malaria cases are increasing in some parts of the world. Furthermore, the drug is designed to prevent both primary types of malaria (P Vivax and P Falciparum) in a convenient, a once-a-week dosing option which could help ensure compliance, whereas other antimalarials require daily dosing.” The company will be working with the US Centers for Disease Control and Prevention (Yellow Book) which will provide guidance on the use of the product and where it can be used. Arakoda could possibly be used in the most malicious areas of the world since it works against both P vivax and P falciparum.
Millions of individuals, particularly military personnel, travel to malaria-endemic regions of the world for work and leisure activities.
According to 60 Degrees, “The approval was based on a concerted effort by the US Army and 60 Degrees, involving over 21 clinical trials and over 3100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.”
The drug is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, tablets should be taken once a week.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.