Summary by Moomoo AI
On August 12, 2024, 60 Degrees Pharmaceuticals, Inc. announced the granting of a right of reference to the University of Kentucky for the company's new drug application for ARAKODA (tafenoquine). This right of reference enables the FDA to review the company's data on ARAKODA as it considers the University of Kentucky's investigational SJ733 Phase IIb program for the treatment of vivax malaria. The Phase IIb study, funded by the Global Health Innovative Technology Fund, will combine SJ733 with a single dose of tafenoquine to assess safety, tolerability, and pharmacokinetics. The University of Kentucky, in collaboration with Eisai Co. Ltd., aims to develop a treatment suitable for all patients with uncomplicated P. vivax malaria. 60 Degrees Pharmaceuticals will supply tafenoquine and placebos for the trial. ARAKODA, approved by the FDA in 2018 for malaria prophylaxis, has been evaluated in several trials for up to six months. The company, which specializes in infectious disease treatments, received FDA approval for ARAKODA in 2018 and collaborates with various research organizations globally.