First new treatment for reccurent malaria approved in over 60 years
pharmafile | July 23, 2018 | News story | Manufacturing and Production | FDA, GSK, approval, malaria, p.vivax
The FDA has approved GSK’s Krintafel for the treatment of a recurring form of malaria in patients aged 16 and older who are receiving appropriate antimalarial therapy for recurring malaria caused by the plasmodium vivax (p. vivax) parasite.
The recurring form of malaria caused by the p. vivax parasite is especially hard to treat as it can lie dormant in the liver for a number of years before reawakening. This is particularly problematic due to the fact that those infected with the dormant malarial parasite can unwittingly carry the species and can thus act as a reservoir from which the disease can be spread by mosquitos. This has made p. vivax particularly hard to eradicate.
The parasite, which is especially prevalent outside of Sub Saharan Africa, affects an estimated 8.5 million people each year.
Dr. Hal Barron, Chief Scientific Officer and President of Research and Development, GSK, commented that: “Today’s approval of Krintafel, the first new treatment for Plasmodium vivax malaria in over 60 years, is a significant milestone for people living with this type of relapsing malaria. 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.”
Krintafel, which acts to flush the p. vivax parasite out of the liver in which it can lie dormant for many years, proved efficacy at a single dose of 300mg. In comparison current treatments often need to be taken for a period of 14 days. The drug can also be taken alongside other medicines used to treat immediate infections.
As expanded upon by Dr David Reddy, Chief Executive Office of the Medicines of Malaria Venture who worked in conjunction with GSK to repurpose the drug: “The US FDA’s approval of Krintafel is a major milestone and a significant contribution towards global efforts to eradicate malaria. 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. We are proud to have worked side-by-side with GSK for more than a decade to reach this point. Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most.”
Louis Goss
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