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US FDA committee votes in favor of 60° Pharmaceuticals' malaria prevention drug


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US FDA committee votes in favor of 60° Pharmaceuticals' malaria prevention drug

60° Pharmaceuticals LLC said a committee of the U.S. Food and Drug Administration voted in favor of its malaria prevention medicine Tafenoquine.

The Washington, D.C.-based privately held company, which is backed by Knight Therapeutics Inc., said the FDA's Antimicrobial Drugs Advisory Committee voted 11 to 2 on Tafenoquine's efficacy and 9 to 4 on the medicine's safety.

The advisory committee provides the FDA with independent advice from outside experts on issues related to infectious diseases and provides recommendations on the safety and efficacy of a drug.

However, the FDA is not required to make a decision based on the recommendation of the committee. An FDA decision on the medicine is still pending.

Tafenoquine, which will be sold as Arakoda, is being touted as a convenient once-a-week dosing option, which could help ensure compliance while traveling. Clinical trials indicate the product is effective against the two primary types of malaria, P. Vivax and P. Falciparum.

In 2014, the company entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity to develop the drug.

Malaria, a life-threatening disease transmitted through the bite of an infected mosquito, caused an estimated 429,000 fatalities and 212 million clinical cases in 2015, according to the U.S. Centers for Disease Control and Prevention. Malaria cases among travelers returning to the U.S. have been trending upward.