Pharmaceutical company 60 Degrees Pharmaceuticals (60P) reported on Thursday the start of distribution of Arakoda (tafenoquine) in the US healthcare marketplace for the prevention of malaria following regulatory approval by the US Food and Drug Administration (FDA).
Arakoda is the first anti-malarial product approved for prevention in over 18 years. Its active ingredient is is tafenoquine, an 8-aminoquinoline chemically derived from Primaquine with activity against all types of malaria. It is supplied in 100 mg tablets for oral use only and is intended to be taken once a week.
The drug is now commercially available via retail pharmacy outlets and pharmaceutical wholesalers, distribution networks as well as third-party insurance companies.
Tafenoquine was discovered by scientists at the Walter Reed Army Institute of Research (WRAIR). The FDA approval was based on a concerted effort by the US Army and 60P, involving over 25 clinical trials and more than 3,000 trial subjects.
Earlier this year, the US Patent and Trademark Office issued a patent covering the use of Arakoda (tafenoquine) tablets for the prevention of symptomatic Plasmodium falciparum malaria in human subjects. The patent's term will provide 60P and the US Army with protection to 2035. Corresponding patent applications are in prosecution in Europe, Canada, Australia and elsewhere.
Emmaus Life Sciences' Endari label enhancements receive US FDA approval
Accord Healthcare introduces Dehydrated Alcohol Injection for cardiovascular indications
CARsgen Therapeutics' satri-cel NDA accepted by Chinese regulator
Sanofi receives FDA orphan drug designation for riliprubart in transplant rejection
Hoth Therapeutics reports positive interim results for HT-001 topical therapy
Breckenridge Pharmaceutical's generic for Ablysinol granted final FDA approval
Hemab Therapeutics presents bleeding disorder clinical and preclinical data at ISTH 2025 Congress
Cumberland Pharmaceuticals reports ifetroban Phase 2 DMD heart disease trial results
Sarclisa recommended for EU approval in newly diagnosed transplant-eligible multiple myeloma