一名患有重生婴儿病的病人,在接受tafenoquine治疗后,经寄生虫检测后没有寄生虫,这显示了接受美国食品和药物管理局首次批准的治疗的希望。 A patient with relapsing babesiosis tested parasite-free after treatment with tafenoquine, showing promise for a first FDA-approved therapy.

60度制药公司报告说,在扩大使用Tafenoquine(ARAKODA)试验中,第一位病人使用两种敏感的分子试验,包括经林业发展局批准的RNA放大试验,对寄生虫进行阴性婴儿病重新复制试验,试验结果为阴性。 60 Degrees Pharmaceuticals reports the first patient in its expanded access trial of tafenoquine (ARAKODA®) for relapsing babesiosis tested negative for the parasite using two sensitive molecular tests, including an FDA-approved RNA amplification test. 患者是免疫抑制患者,之前的治疗都失败,治疗结束后60天没有检测到巴贝西亚,这支持了早期发现的高治愈率. The patient, an immunosuppressed individual who failed prior treatments, showed no detectable Babesia 60 days after completing therapy, supporting earlier findings of high cure rates. 目前尚无 FDA 批准的巴贝虫病治疗方法，巴贝虫病是东北部一种日益严重的蜱传疾病，可能危及生命。 No FDA-approved treatment exists for babesiosis, a rising tick-borne illness in the Northeast that can be life-threatening. 该公司于2025年10月3日向林业发展局提交了突破治疗指认申请,并计划于2026年初举行B型会议,讨论补充NDA。 The company submitted a Breakthrough Therapy Designation request to the FDA on October 3, 2025, and plans a Type B meeting in early 2026 to discuss a supplemental NDA. 这项研究预计于2026年10月结束,是目前正在进行的三项试验的一部分,评估塔费诺奎因在婴儿病方面的潜力,预计2026年底会有数据。 The study, expected to conclude by October 2026, is part of three ongoing trials assessing tafenoquine’s potential in babesiosis, with data anticipated in late 2026. 目前,美国批准了预防疟疾的塔菲诺奎因。 Tafenoquine is currently approved in the U.S. for malaria prevention.