FDA approves new drug for the treatment of malaria



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A new drug to treat malaria could help millions of people.

The Food and Drug Administration approved the drug Krintafel (tafenoquine) for the treatment of malaria following a priority review last Friday.

The drug, developed by GSK Pharmaceuticals and Medicines for Malaria Venture, is a single-dose drug designed for people who have ever had malaria. It prevents the relapse of malaria caused by Plasmodium vivax (P.vivax).

P.vivax is one of many parasites of the Plasmodium family known to cause malaria. It represents infection with malaria in 15-20% of cases around the world; this is about 8.5 million infections per year.

Unlike his cousin Plasmodium falciparum, which is responsible for about 75% of cases, following initial infection in the blood, P. vivax can pass to a dormant stage in the liver, where the most antimalarial drugs can not reach it.

Currently, patients with P.vivax require a 10-day treatment with the drug Primaquine to eradicate these dormant liver parasites. Many patients, much to the frustration of the doctors, do not complete the 10 days of treatment, which leads to the survival of the parasite and the recurrence of malaria.

Krintafel, approved last Friday, eradicates dormant P. vivax parasites after one dose.

Dr. David Reddy, general manager of Medicines for Malaria Venture, said in a press release, "The approval of Krintafel by the US FDA is an important step and a significant contribution to global efforts to eradicate malaria. The world has been waiting decades for a new drug to counter the relapse of P. vivax malaria. Today, we can say that the wait is over. In addition, as the first single dose for this indication, Krintafel will help improve patient compliance. We are proud to have worked side by side with GSK for more than a decade to reach this point. Our goal now is to work to get the drug to the most vulnerable patients who need it most. "

The efficacy and safety of the drug have been established in two large randomized studies published in the summer of 2017. Manufacturers warn patients with deficiency of an enzyme in red blood cells called G6PD , women who are breastfeeding a child with a G6PD deficiency, or someone who has not been tested for this condition, should not take Krintafel because of the risk of worsening the condition. ;anemia.

In an interview with ABC News, Dr. Regina Rabinovich, President of the American Society of Tropical Medicine and Hygiene (ASTMH) and ExxonMobil Malaria Scholar in residence at Harvard University, congratulated the Team involved in this effort, as they 'attack part of the burden of malaria often overlooked by the global agenda.P vivax was considered benign but it is not benign ".

Does this drug supplement what doctors need in global malaria efforts? Dr. Rabinovich says, "There is no miracle solution to malaria." She emphasizes the importance of a multidimensional approach: "We need basic prevention technologies, surveillance and surveillance. reporting, truly effective health systems and monitoring. You must be able to do something to help once you have identified a problem. "

According to the 2017 report of the World Health Organization, in 2016 an estimated 216 million cases of malaria, an increase of about 5 million compared to 2015, putting in guard against progress and previous efforts.

Dr. Rabinovich worries about the 2018 report, which will be released later this year, could be even worse, partly because of the dwindling global funding for malaria prevention.

Dr. Edith Bracho-Sanchez is a pediatrician working for the ABC Medical Unit.

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