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60° Pharmaceuticals-US Army's malaria drug clears US FDA

The U.S. Food and Drug Administration approved 60° Pharmaceuticals LLC's Arakoda, or tafenoquine, tablets to prevent malaria in patients 18 years and older.

The acceptance is one of the first approvals for a new drug to prevent malaria in more than 18 years, 60° Pharmaceuticals said in an Aug. 9 press release.

Currently available for use in 100-milligram oral tablets, Arakoda is administered initially through a loading dose followed by weekly doses. A loading dose is an initial high dose administered at the start of a treatment before dropping to a lower maintenance dose.

Arakoda was developed by scientists at the Walter Reed Army Institute of Research. The U.S. Army and 60° Pharmaceuticals worked together in more than 21 clinical trials with more than 3,100 patients to develop Arakoda as a preventative anti-malarial drug.

"Arakoda provides effective protection against both of the major types of malaria, killing the parasites in both the blood and liver," Geoffrey Dow, CEO of 60° Pharmaceuticals, said. "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."

In July, the FDA's Antimicrobial Drugs Advisory Committee, which provides independent advice on infectious diseases and recommendations on the safety and efficacy of drugs, voted in favor of Arakoda.

Washington, D.C.-based 60° Pharmaceuticals has agreed to perform post-marketing safety surveillance studies to continue gathering data on the drug.

GlaxoSmithKline PLC also gained approval in July for its drug Krintafel, which treats a certain type of malaria called plasmodium vivax. Krintafel prevents the relapse of malaria in patients at least 16 years old who are receiving appropriate anti-malarial therapy.

Cases of malaria rose slightly in 2016, to 216 million, compared with 211 million in 2015, according to the WHO's "World Malaria Report." About 90% of malaria cases and more than 90% of related deaths occurred in sub-Saharan Africa. About 445,000 people died of malaria in 2016, compared with 446,000 in 2015. Meanwhile, research and development in neglected diseases has declined slightly, the WHO said.