60 Degrees Pharmaceuticals seeks FDA priority voucher for babesiosis drug

On September 12, 2026, 60 Degrees Pharmaceuticals, Inc. submitted a Statement of Interest to the FDA requesting a Commissioner's National Priority Voucher designated for an efficacy supplement to NDA 210607 for ARAKODA (tafenoquine) for the treatment of babesiosis.¹

Babesiosis is described in the filing as an expanding tick-borne parasitic infection in the United States for which there is currently no FDA-approved therapy.¹ The company said the illness poses heightened risk for patients with weakened immune systems, who can face extended or recurring infection even after lengthy courses of antimicrobial drugs used off-label, and who face markedly higher death rates. 60 Degrees stated that it is the only sponsor with an FDA authorized randomized placebo-controlled trial and an expanded access study in babesiosis.¹

On efficacy, the company pointed to outside case report data showing tafenoquine combined with atovaquone-based therapy cured roughly 83% of patients whose infections had relapsed, with cure rates nearing 100% when dosing continued until parasites cleared, according to published reports cited in the filing. In the company's own expanded access study, tracked under NCT06478641, all three currently evaluable patients have been cured, as confirmed using an FDA-approved RNA amplification assay.¹

The company is also running NCT06207370, a randomized, double-blind, placebo-controlled trial of tafenoquine plus standard of care versus placebo plus standard of care in hospitalized babesiosis patients at five Northeastern hospitals.¹ Enrollment required for the prespecified interim analysis is complete, and the Data Safety Monitoring Board analysis is scheduled for October 1, 2026.¹

Based on that interim readout, the company said it would decide between a standard approval route backed by the randomized trial data or an accelerated approval route relying on expanded-access results and published literature, paired with a follow-up confirmatory study. The target supplemental New Drug Application submission is March-April 2027.¹ The company has also committed to manufacture more than 50% of the value of future CNPV-supported products in the United States and to provide volume-based discounts to federal programs.¹