林业发展局核准为抗药性淋病提供新的口服抗生素Zoliflodacin,预计2026年底供应。
FDA approves new oral antibiotic zoliflodacin for drug-resistant gonorrhea, with availability expected in late 2026.
林业发展局批准了Zoliflodacin,这是一种新的口服抗生素,用于治疗12岁及12岁以上的病人中不复杂的泌尿素性淋病,这标志着数十年来的首次新治疗。
The FDA has approved zoliflodacin, a new oral antibiotic, for treating uncomplicated urogenital gonorrhea in patients 12 and older, marking the first new treatment in decades.
它对耐药菌株有效,包括对和亚胺素耐药的菌株,并以单次3克剂量给予.
It is effective against drug-resistant strains, including those resistant to ceftriaxone and azithromycin, and is given as a single 3-gram dose.
根据有930人参加的第3阶段试验核准,其治疗率与目前的治疗方法相似。
Approved based on a phase 3 trial with 930 participants, it showed similar cure rates to current treatments.
预计该药物将于2026年底提供。
The drug is expected to be available in late 2026.
大约在同一时间,还批准了第二个抗生素(gepotidacin)。
A second antibiotic, gepotidacin, was also approved around the same time.
批准被视为解决抗药性淋病不断上升问题的关键步骤,这种疾病影响到全球数百万人,被世卫组织列为优先病原体。
The approvals are seen as critical steps in addressing rising drug-resistant gonorrhea, which affects millions globally and is classified as a priority pathogen by the WHO.