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GlaxoSmithKline treatment wins US FDA approval to prevent malaria relapse


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GlaxoSmithKline treatment wins US FDA approval to prevent malaria relapse

GlaxoSmithKline PLC and Medicines for Malaria Venture said the U.S. Food and Drug Administration approved the medicine Krintafel to prevent the relapse of a particular type of malaria.

The single-dose Krintafel, or tafenoquine, was approved to prevent relapse of Plasmodium vivax malaria in patients over 16 years of age who are receiving appropriate antimalarial therapy for acute Plasmodium vivax, or P. vivax, malaria.

After an infected mosquito bite, the P. vivax parasite infects the blood and causes an acute malaria episode. It also has the ability to lie dormant in the liver from where it periodically reactivates to cause relapses of P. vivax malaria.

GlaxoSmithKline's Chief Scientific Officer and President of Research and Development Hal Barron said Krintafel is the first new medicine in over 60 years that is intended to keep the strain of malaria from coming back.

Earlier in the year, the U.K.-based pharmaceutical giant had said it would invest £175 million to advance research and development of a new, single-dose treatment for relapsing malaria and for piloting the implementation of the world's first malaria vaccine.

Krintafel was originally synthesized by scientists at the Walter Reed Army Institute of Research in 1978, and GlaxoSmithKline entered a collaboration with Medicines for Malaria to develop it in 2008.

GlaxoSmithKline said the approval was based on positive data from multiple trials which showed the efficacy and safety of Krintafel.

In November 2017, GlaxoSmithKline submitted a new drug application to the FDA seeking approval for the drug. A regulatory submission was made to the Australian Therapeutic Goods Administration in December 2017, the decision for which is still pending.

According to the World Health Organization's World Malaria Report, there were 216 million cases of malaria in 2016, up from 211 million cases in 2015. The Commonwealth nations account for more than half of global malaria cases and deaths while being one-third of the world's population.