Iterum Therapeutics 的 ORLYNVAH 获得 FDA 批准,这是第一个用于治疗成年女性 uUTI 的口服青药。 Iterum Therapeutics receives FDA approval for ORLYNVAH, the first oral penem for uUTI treatment in adult women.
Iterum Therapeutics 的 ORLYNVAH(口服磺罗培南)已获得美国 FDA 的批准,这是第一个用于治疗治疗选择较少的成年女性无并发症的尿路感染 (uUTI) 的口服青药。 Iterum Therapeutics has gained U.S. FDA approval for ORLYNVAH (oral sulopenem), the first oral penem for treating uncomplicated urinary tract infections (uUTIs) in adult women with few treatment options. 这是20年来FDA批准的第二种尿路感染治疗. This marks the second FDA-approved uUTI treatment in 20 years. 核准的依据是,与现有的抗生素相比,第三阶段的两个试验显示其安全和功效。 The approval was based on two Phase 3 trials showing its safety and efficacy compared to existing antibiotics. 定于10月28日举行一次电话会议,讨论批准事宜。 A conference call is scheduled for October 28 to discuss the approval.