The new drug, Krintafel (Tafenoquine), may be an important step towards eliminating the mosquito-borne disease.
The drug was developed by GSK and Medicines for Malaria Venture. The project drew on funding from the Bill and Melinda Gates Foundation.
Krifantel treats p. vivax malaria, the second most frequently occurring strain of malaria. The approval marks the first new treatment for the strain in more than 60 years.
Malaria causes fevers, malaise, nausea and chills and more extreme cases can result in comas and eventual death. Symptoms of the disease can recur in patients months or even years after infection.
The most recent survey of malaria undertaken by the World Health Organization (WHO) in 2016 found there were 216 million cases of malaria worldwide and had caused 445,000 deaths in that calendar year. Around 90% of the deaths occur in sub-Saharan Africa and many of the victims are young children.
First malaria drug in 60 years given approval https://t.co/GIt6P6prOT
— BBC News (UK) (@BBCNews) July 23, 2018
The WHO has previously set a target of reducing malaria mortality by 90% by 2020 and has said that the sector needs much greater funding to meet this goal.
Malaria No More hails approval of the new drug as a major milestone
“This new drug is an important breakthrough, and making it available quickly will help reduce malaria cases globally, especially in Asia and the Americas” said Martin Edlund, CEO of nonprofit organisation Malaria No More.
The @US_FDA has approved an important new antimalarial – first in over 60 years. Krintafel (tafenoquine) is the result of 40 years of investment in R&D, first started in 1978 by the US government, then developed by @MedsforMalaria & @GSK. https://t.co/rqqW2tTFrH #EndMalaria pic.twitter.com/4UgEacgcjp
— Malaria No More (@MalariaNoMore) July 21, 2018
“To save millions of lives from malaria and ultimately end this diseases, we need novel tools like Krintafel, and to continue investing in a pipeline of innovation.”
Krifantel is suitable for patients 16 years and older and presents the relapse of the malaria strain. Previous medicine targeting the strain had required multiple doses over a period of 14 days to be effective.
— GSK (@GSK) July 21, 2018
Edlund said the drug will be particularly important in South Asia. “India is the proving ground for humanity’s ambition to end diseases; It was with smallpox, and polio, and now it will be for malaria.
“As Malaria No More works to support India’s goal to eliminate malaria by 2030, having Krintafel available could make a huge difference.”
Dr. David Reddy, CEO of Medicines for Malaria Venture, the non-profit public-private partnership that worked with GSK on the medicine, said tafenoquine had been more than a decade in the making and represents a “major milestone” towards malaria eradication.
“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.
“Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most.”
The next step will be to gain regulatory approval for the drug in countries where malaria is prevalent.