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FDA approves new single dose malaria drug

A new drug called Krintafel (tafenoquine) has been approved by the U.S. Food and Drug Administration (FDA) to contribute greatly towards eliminating malaria, particularly in Asia and the Americas.

Developed by GSK and Medicines for Malaria Venture with funding from the Bill & Melinda Gates Foundation, Krintafel is the first new treatment for P. vivax malaria in more than 60 years.

“This new drug is an important breakthrough, and making it available quickly will help reduce malaria cases globally, especially in Asia and the Americas,” Martin Edlund, CEO of Malaria No More, said.

“To save millions of lives from malaria and ultimately end this disease, we need novel tools like Krintafel, and to continue investing in a pipeline of innovation.”

Krintafel is a safe, single-dose, “radical cure” treatment for people aged 16 years and older that prevents the relapse of P. vivax malaria, the second most common strain of the parasite.

Estimated to cause around 8.5 million infections every year, vivax especially affects people living in some of the world’s most densely populated regions.

“India is the proving ground for humanity’s ambition to end diseases; It was with smallpox, and polio, and now it will be for malaria.,” said Edlund.

“As Malaria No More works to support India’s goal to eliminate malaria by 2030, having Krintafel available could make a huge difference.”

Latin America, which reduced malaria cases by more than 61 percent from 2000-2015, also could benefit from the new drug.

Before Krintafel, there was only one approved treatment for vivax malaria called primaquine. While clinically effective, primaquine requires at least several doses, which often means several visits to a health clinic.

Krintafel is the result of four decades of investment in research and development, which started in 1978 by scientists at the U.S. Walter Reed Army Institute of Research.

It was then brought forward by GSK in collaboration with the not-for-profit drug research partnership, Medicines for Malaria Venture.

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