FDA OKs Tafenoquine (Krintafel) to Prevent Malaria Relapse

Megan Brooks

Disclosures

July 23, 2018

The US Food and Drug Administration (FDA) has approved tafenoquine (Krintafel) to prevent relapse of Plasmodium vivax malaria in people aged 16 years and older who are receiving appropriate antimalarial therapy for acute P vivax infection, GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) have announced.

Tafenoquine is the first new treatment for P vivax malaria in more than 60 years and is the first single-dose medicine for this type of relapsing malaria, according to GSK. Tafenoquine had breakthrough status and was approved under priority review.

"Together with our partner, Medicines for Malaria Venture, we believe Krintafel will be an important medicine for patients with malaria and contribute to the ongoing effort to eradicate this disease," Hal Barron, MD, GSK chief scientific officer and president of research and development, said in a statement.

"The US FDA's approval of Krintafel is a major milestone and a significant contribution towards global efforts to eradicate malaria," added David Reddy, PhD, MMV chief executive officer. "The world has waited decades for a new medicine to counter P vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single dose for this indication, Krintafel will help improve patient compliance. Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most."

Tafenoquine is an 8-aminoquinoline derivative that is active against all stages of the P vivax life cycle. It was first synthesized by scientists at the Walter Reed Army Institute of Research, Silver Spring, Maryland, in 1978. GSK started developing tafenoquine as a potential antimalarial more than 20 years ago. In 2008, the company entered into a collaboration with MMV, a nonprofit drug research partnership, to develop tafenoquine.

In approving the medicine, the FDA reviewed data from 33 studies involving more than 4000 participants who receifved the 300-mg single dose and other doses of tafenoquine.

It is estimated that P vivax malaria causes about 8.5 million clinical infections every year. It has a significant public health and economic impact, primarily in South Asia, Southeast Asia, Latin America, and the horn of Africa.

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