The US Food and Drug Administration FDA has approved Tapenochin ( Krintafel ) to prevent recurrence of Plasmodium vivax malaria in individuals 16 years of age and older who receive appropriate antimalarial therapy for acute P vivax Infection, GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) have been announced
Tafenoquine is the first new treatment for P vivax malaria in over 60 years and years the first single-dose drug for this type of recurrent malaria, according to GSK. Tafenoquine had breakthrough status and was approved in a priority review.
"We believe that together with our partner Medicines for Malaria Venture, Krintafel will be an important drug for patients with malaria and will contribute to the ongoing efforts to eradicate this disease," said Barron, MD, GSK Chief Scientific Officer and President of Research and Development, said in a statement.
"The approval of Krintafel by the US FDA is an important milestone and an important contribution to the global fight against malaria," added David Reddy. PhD, MMV Chairman of the Board. "The world has been waiting decades for a new drug to counter the P vivax malaria relapse." Today, we can say that the wait is over. "In addition, Krintafel will be the first single dose for this indication to help improve patients focus now on ensuring that medicine reaches the most vulnerable patients they most need. "
Tafenoquine is an 8-aminoquinoline derivative active against all phases of the P vivax life cycle. It was first synthesized in 1
In the approval of the drug, the FDA reviewed data from 33 studies involving more than 4,000 participants who received the 300 mg single dose and other doses of tafenoquine
It is estimated that P vivax Malaria causes about 8.5 million clinical infections each year. It has a significant impact on public health and the economy, especially in South Asia, Southeast Asia, Latin America and the Horn of Africa.
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