FDA gives green light to 60 Degrees Pharmaceutical’s Arakoda for malaria prevention
The Food and Drug Administration has given the nod to 60 Degrees Pharmaceuticals’ Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older.
Malaria is a life-threatening disease transmitted through the bite of an infected mosquito.
This is the first FDA approval of a new drug for the prevention of malaria in 18 years.
Arakoda is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, it is intended to be taken once a week.
Tafenoquine is an 8-aminoquinoline chemically derived from primaquine, with activity against all types of malaria Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research (WRAIR).
The approval was based on a collaborative effort by the United States Army and 60P, involving over 21 clinical trials and over 3,100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.
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