GlaxoSmithKline ($GSK) has picked up the FDA's coveted "breakthrough therapy" designation for its investigative malaria therapy, news that could shave months off of the drug's development time.
Tafenoquine, part of a partnership with Medicines for Malaria Venture, is a one-time treatment for Plasmodium vivax malaria, a form of the disease that can sit dormant in the liver for months before triggering a relapse. P. vivax affects between 70 million and 390 million patients each year, GSK said, and the drug's long half-life makes for a more tolerable treatment than repeated doses of the effective but side-effect-prone primaquine.
The FDA's move to fast-track tafenoquine comes after a Phase II study in which the drug hit its endpoint of relapse-free efficacy at 6 months, beating out standard treatment while clocking similar safety results. GSK plans to kick off a Phase III trial next year.
P. vivax malaria is most common in South and Southeast Asia, Latin America and the horn of Africa, GSK said, and tafenoquine, not yet approved anywhere in the world, holds promise for millions in underserved geographies.
GSK's treatment joins a growing list of promising therapies for life-threatening diseases under the FDA's new breakthrough umbrella, instituted this year. Three such drugs have since won approval, speeding up their paths to market by months.
- read the announcement
- check out the Phase II results