Sixty Degrees Pharmaceuticals, Inc. (SXTP) announced on Tuesday that the U.S. Food and Drug Administration or FDA does not object to the company's plan to import KODATEF, the Australian version of tafenoquine, as a preemptive measure to avoid potential disruptions in the U.S. supply of ARAKODA.
ARAKODA, an antimalarial medication used for malaria prophylaxis in adults, has seen growing demand in the U.S. as its use expands.
To ensure a continuous supply, Sixty Degrees Pharmaceuticals will import a five-month supply of KODATEF, which is identical to ARAKODA in terms of dosing regimens, safety, efficacy, and mechanisms of action, although it is not approved for use in the U.S.
The company is also working to increase the long-term manufacturing output of ARAKODA.
Both ARAKODA and KODATEF are approved for malaria prevention in the U.S. and Australia, respectively, with tafenoquine offering the benefit of less frequent dosing due to its long half-life of approximately 16 days.
60 Degrees Pharmaceuticals remains committed to ensuring that tafenoquine continues to be available for malaria prevention, demonstrating its proactive approach to maintaining supply availability for healthcare providers.
Currently, SXTP is trading at $0.66 up by 9.00%.
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