60 Degrees Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged ≥18 years—the first prophylactic agent to be approved in more than 18 years.
Arakoda, an 8-aminoquinoline, is chemically derived from the aminoquinoline Primaquine (primaquine phosphate; Sanofi). It is thought to exert its effect by inhibiting hematin polymerization and inducing apoptotic like death of the parasite. Arakoda is active against all stages of Plasmodium species and also causes red blood cell shrinkage in vitro.
Arakoda is intended for dosing as follows: a loading regimen taken daily for 3 days prior to travel to an endemic area, a weekly dose while in the malarious area, then a one-time terminal prophylaxis dose in the week following exit from the malarious area.
The approval of Arakoda was based on over 21 trials involving over 3100 patients. In Trial 1 (N=123), prophylaxis with Arakoda demonstrated 73.3% protective efficacy (98.3% CI, 54.0%, 84.5%) vs placebo. In Trial 2 (N=187), protective efficacy with Arakoda was 71.3% (98.75% CI, 55.8%, 81.4%) vs placebo. The most common adverse effects associated with Arakoda were headache, dizziness, back pain, diarrhea, nausea, vomiting, increased ALT, motion sickness, insomnia, depression, abnormal dreams, and anxiety.
Prior to prescribing Arakoda, patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency as it is contraindicated in those with a G6PD deficiency or an unknown status. Arakoda will be available as 100mg tablets in 8-count blister cards.
For more information visit 60degreespharma.com.