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The FDA approved tafenoquine (Krintafel) for the "radical cure" of malaria in Plasmodium vivax in patients aged 16 years and older receiving antimalarial treatment for acute infection, the manufacturer said GlaxoSmithKline (GSK).
The approval was based primarily on data from three randomized trials that tested tafenoquine in a single 300 mg dose in more than 800 people, and which was strongly endorsed by an FDA advisory committee in the United States. beginning of the month
. the Advisory Committee on Antimicrobial Drugs voted unanimously (13-0) in favor of the recommendation for approval, a member having qualified the data as "slam dunk". On safety, the drug was recommended for approval with a 12-1 vote, with postmarketing studies recommended to address concerns about psychosis, anemia, and nausea.
The drug was developed by Medicines for Malaria Venture (MMV). collaboration with GSK, as an alternative to primaquine, which is currently the only recurrent malaria drug. Over a 14-day period, primaquine can cause serious adverse events in some patients.
In a randomized study comparing chloroquine and tafenoquine or primaquine, the relapse rate at 6 months was similar between the two: 67.0 The world waited for decades for a new drug to counteract the relapse of malaria … Today, we can say that the wait is over, "said David Reddy., PhD, general manager of MMV." Our goal now is to work for the drug reaches the most vulnerable patients who need it most. "
The newly approved drug is contraindicated in patients with allergies to tafenoquine or other agents containing 8-aminoquinoline. glucose-6-phosphate dehydrogenase (G6PD) Patients should be tested if their status is unknown
Similarly, tafenoquine should not be given to women who are badfeeding a child with G6P deficiency D or to a child who has not yet been screened.
Another formulation of tafenoquine, developed by 60 Degrees Pharmaceuticals with a proposed indication of malaria prevention, is currently under FDA review; The agency's Advisory Committee on Antimicrobial Drugs will review this product this Friday.
2018-07-23T17: 15: 00-0400
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