FDA Approves Tafenoquine for Malaria Prevention

AUGUST 09, 2018
Cecilia Pessoa Gingerich
omadacycline, paratek, CABP, ABSSSI, FDA, committee, PDUFAThe US Food and Drug Administration (FDA) has approved a new drug for the prevention of malaria in patients 18 years of age and older. Tafenoquine (Arakoda) is the first drug for malaria prevention to be approved in the US in 18 years.

"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," said Geoffrey Dow, PhD, CEO of 60 Degrees Pharmaceuticals.

The prophylactic drug was originally discovered by researchers at the Walter Reed Army Institute of Research (WRAIR) in 1978 and the drug was developed jointly between the US Army and 60 Degrees Pharmaceuticals (60P) starting in 2014.

"FDA approval is a tremendous achievement for 60P and the US military for their long, dedicated effort in the global protection of Service Members and civilian personnel against malaria," said MAJ Victor Zottig, the product manager of tafenoquine for the US Army Medical Materiel Development Activity.

An FDA advisory committee convened in July voted to support tafenoquine for this indication, with stronger support for its efficacy (11 for, 2 against) than its safety (9 for, 4 against). The drug was approved in July as GSK’s Krintafel, a single-dose treatment for the prevention of relapse of Plasmodium vivax malaria in patients aged 16 years and older.

Tafenoquine as a preventative is provided in 100 mg tablets to be taken once each week to prevent malaria. There is also an initial loading dose to be taken prior to travel to an area where malaria is endemic.

The tafenoquine approval, says Dow “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."

Noted adverse reactions (incidence ≥1%) include: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams and anxiety.

Tafenoquine should not be administered to patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency or unknown G6PD status, and women taking the preventative should not breastfeed infants who are G6PD-deficient. Additionally, tafenoquine should not be taken with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters.

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