Single-dose tafenoquine for radical cure of P. vivax malaria submitted for regulatory approval in Brazil

Brazil becomes the first malaria-endemic country to review the regulatory dossier for the new medicine

21 Sep 2018

A Marketing Authorization Application for tafenoquine for radical cure (prevention of relapse) of P. vivax malaria has been submitted by GSK to the Brazilian Health Regulatory Agency (ANVISA) under a priority review, making Brazil the first malaria-endemic country to evaluate the new single dose anti-relapse medicine. A priority review has been granted.

Tafenoquine, developed by GSK and MMV, was approved in July 2018 by the US Food and Drug Administration for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older and in September 2018 by the Australian Therapeutic Goods Administration. The medicine needs to be co-administered with an appropriate blood-stage antimalarial therapy to treat the acute P. vivax malaria infection.

P. vivax malaria has a significant public health and economic impact, primarily in South Asia, South-East Asia, the horn of Africa and Latin America. Brazil is one of the Latin American countries with the heaviest burden of P. vivax malaria. In 2016, there were over 110,000 reported cases of P. vivax malaria in the country, mainly in the Amazon region.

Over the last 20-30 years in Brazil, there has been a steady decline in the proportion of cases due to Plasmodium falciparum. As a result, in 2016, P. vivax was reported to be the cause of almost 90% of Brazil’s malaria cases. P. vivax malaria is debilitating in particular because of its recurrent infections due to relapses and has substantial economic impact on families and nations. The clinical features of P. vivax malaria include fever, chills, vomiting, malaise, headache and muscle pain and, in some cases, can be fatal.

The clinical trials of tafenoquine were conducted in nine malaria-endemic countries including Brazil.

“Submission of the tafenoquine dossier to the Brazilian regulatory agency is an exciting step along the road to getting tafenoquine to patients that need it,” said Dr David Reddy, MMV’s CEO. “MMV is proud to have worked side-by-side with GSK for more than a decade to reach this milestone, and we look forward to Brazil’s regulatory decision.”

"Brazil is a country where the vast majority of malaria cases are caused by P. vivax, which means malaria relapse is a big issue,” said Dr Marcus Lacerda, Fiocruz/Tropical Medicine Foundation Heitor Dourado, Manaus, Brazil. “As such, if approved in Brazil, we consider tafenoquine could be a new tool for the management of malaria that would reduce the overall burden of disease.''