21. Krintafel

GSK building
(GlaxoSmithKline)

Active ingredient: tafenoquine 
Disease: Plasmodium vivax malaria 
Peak sales estimate: n/a
Approved: July 20 
Company: GlaxoSmithKline 

The scoop: GlaxoSmithKline worked on tafenoquine with Medicines for Malaria Venture to create a “radical cure” for malaria, that is, one that would clear up infection and stop it from returning. And last July, after spending 12 years in development, Krintafel became the newest treatment for Plasmodium vivax malaria—one of the most common forms of the disease—in 60 years. Its long half-life in the body enables it to prevent relapse with one dose, unlike the treatment primaquine, which must be given daily for two weeks. Investigators used primaquine as the comparator arm in the phase 3 study supporting Krintafel’s marketing application. While P. vivax isn’t the deadliest malaria parasite, P. falciparum, it is more widespread, affecting 16 million people in 2013 by the World Health Organization’s count. The WHO considers P. vivax the main barrier to its goal of eliminating malaria worldwide by 2030. Since its FDA nod, tafenoquine has been approved in Australia, which could help set up registrations in countries where P. vivax is endemic and pave the way for WHO prequalification. — Amirah Al Idrus 

21. Krintafel
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