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60 Degrees Pharmaceuticals Receives FDA Orphan Drug Designation for Tafenoquine for Treatment of Patients with Acute Babesiosis
With the tafenoquine for acute babesiosis orphan drug designation, 60 Degrees Pharmaceuticals now qualifies for certain incentives, including market
About this update from 60 Degrees Pharmaceuticals, Inc.
[{"type":"text","content":"With the tafenoquine for acute babesiosis orphan drug designation, 60 Degrees Pharmaceuticals now qualifies for certain incentives, including market exclusivity, tax credits, and exemption from certain FDA filing fees.60 Degrees Pharmaceuticals recently announced it has entered into an agreement with Tufts Medical Center in Boston to conduct the world’s first clinical trial evaluating the efficacy and safety of tafenoquine in treating human babesiosis patients.FDA orphan drug designation is granted for therapeutic candidates that may prevent or treat a rare disease or condition, such as acute babesiosis. WASHINGTON, June 11, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or “60 Degrees Pharmaceuticals”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the U.S. Food and Drug Administration (“FDA”) has granted its investigational tafenoquine candidate orphan drug designation for the treatment of patients with acute babesiosis. FDA orphan drug designation is granted for therapeutic candidates that may prevent or treat a rare disease or condition, such as acute babesiosis. Babesiosis is a steadily emerging, infectious disease transmitted by a microscopic parasite, Babesia, through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease. Babesiosis may be life-threatening in elderly and immunosuppressed patients. Up to 10 percent of Lyme disease patients may be coinfected with Babesia. Therefore, up to 47,600 of the estimated 476,000 patients with new Lyme infections each year may be co-infected with Babesia. “Results of recent animal studies of tafenoquine show exciting promise for the drug to have potential in human patients with acute babesiosis,” said Chief Executive Officer of 60 Degrees Pharmaceuticals, Geoff Dow, PhD. “The FDA granting tafenoquine orphan drug designation for acute babesiosis validates the growing need for an additional therapeutic option that infectious disease specialists can use in addressing this very serious, potentially life-threatening illness. We look forward to results of our clinical trial program in coming months and to the prospect of securing a secondary indication for tafenoquine in the area of acute babesiosis treatment.” 60 Degrees Pharmaceuticals recently announced i...