GSK Brazil and Medicines for Malaria Venture (MMV) today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted  Marketing Authorization Approval, under Priority Review, for single-dose tafenoquine (brand name Kozenis) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving chloroquine for acute P. vivax (blood-stage) infection.

Mature Plasmodium vivax schizont/CDC

The Ministry of Health, in partnership with MMV, will conduct a study to understand the feasibility of implementing quantitative point-of-care G6PD testing with tafenoquine in real-world settings before treatment is made available in Brazil. This study, known as TRuST is being conducted in the municipalities of Manaus and Porto Velho. The study outcomes, expected in the first quarter of 2021, will assist the Ministry of Health to determine how to best deploy tafenoquine in P. vivax endemic areas.

As a single dose cure, tafenoquine facilitates compliance and therefore aims to overcome one of the major limitations of the only other approved medicine for radical cure of P. vivax malaria, primaquine, which needs to be taken over 7 or 14 days.

According to Dr. Marcus Lacerda, Director of Research at the Tropical Medicine Foundation Doctor Heitor Vieira Dourado (FMT-HVD) of Manaus: “This approval is an important step forward for malaria control and elimination in Brazil and in the Amazon region. After years of research, and following completion of the feasibility study, we hope to finally have a new tool that is appropriate for use in the population that is vulnerable to malaria – enabling patients to complete the treatment course.”

“Globally, the human and economic cost of relapsing malaria is high” said Dr David Reddy, MMV’s CEO. “Each malaria episode keeps a child from school or an adult from work and in susceptible individuals the disease can potentially be fatal. Moreover, as gains are made against the other key malaria parasite, P. falciparum, we’re seeing the proportion of cases of P. vivax increase. That’s why the approval of this new tool, tafenoquine, in the first malaria-endemic country is so important. As a single dose medicine, we hope that tafenoquine will increase patient adherence and help countries, like Brazil, move closer to malaria elimination.”

The President of GSK’s pharmaceutical division in Brazil, José Carlos Felner said: “The approval of tafenoquine in Brazil marks another important step in the fight against neglected diseases. In 2018 alone, the Ministry of Health recorded over 194,000 cases of malaria. We are now awaiting the completion of feasibility studies that will help determine next steps on how best to direct patient access to tafenoquine in Brazil as part of global efforts to eradicate malaria.”