Babesiosis

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60 Degrees Pharmaceuticals to Submit MUMS (Minor Use/Minor Species) Designation Request to FDA for Tafenoquine for Acute Canine Babesiosis in 2025
Globenewswire· 2025-07-14 20:01
Data from three independent clinical studies demonstrate utility of tafenoquine to treat acute canine babesiosis WASHINGTON, July 14, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced that the Company will conduct a gap analysis of its existing data prior to submitting a Minor Use Minor Species (MUMS) designation request to the United States Foo ...
Babesiosis Incidence in U.S. 10x Higher Than CDC Estimates, According to Insurance Claims Study Commissioned by 60 Degrees Pharmaceuticals
Globenewswire· 2025-06-03 12:49
Core Insights - 60 Degrees Pharmaceuticals, Inc. announced results from an insurance claims analysis indicating a significant discrepancy between the number of Americans seeking reimbursement for babesiosis-related medical costs and CDC estimates of actual cases [1][2][10] - The company is investigating the true burden of babesiosis, particularly its association with chronic fatigue, through ongoing clinical trials and studies [6][8][10] Claims Analysis - Approximately 25,000 Americans seek reimbursement for babesiosis-related medical costs annually, while CDC estimates only 2,000 cases in 2020 [2][10] - Claims data revealed that about 31% of babesiosis cases persist longer than 30 days, with nearly half of these cases associated with chronic fatigue lasting over six months [4][10] Chronic Fatigue Insights - Babesia infections can last at least 12 months in 14% of patients, with potential relapses occurring up to 27 months later [3] - Over three years, more than 12 million U.S. adults experienced chronic fatigue lasting more than six months, yet current guidelines do not mandate babesiosis as a differential diagnosis for such fatigue [5][10] Clinical Development - The company is conducting clinical trials to evaluate the safety and efficacy of tafenoquine in treating babesiosis, with data expected in the first half of 2026 [8][10] - A new drug application (NDA) for babesiosis is anticipated to be submitted to the FDA in 2026 [8][10] Product Information - Tafenoquine, marketed as ARAKODA, was approved for malaria prophylaxis in 2018 and is available as a prescription-only medication [9][10] - The drug has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [9]