FDA批准了Bayer的非激素药物Lynkuet(Lynkuet),用于中度至严重程度的更年期热火花,2025年11月提供。
The FDA approved Bayer’s non-hormonal drug Lynkuet for moderate-to-severe menopausal hot flashes, available November 2025.
美国林业发展局根据三次后期试验的结果,批准Bayer的非激素药物Lynkuet用于治疗更年期女性中度至严重程度的热发。
The U.S. FDA has approved Bayer’s non-hormonal drug Lynkuet for treating moderate-to-severe hot flashes in menopausal women, based on results from three late-stage trials.
每天一次的胶囊在睡觉时使用,减少症状的频率和严重程度,改善睡眠状况。
The once-daily capsule, to be taken at bedtime, reduces symptom frequency and severity and improves sleep.
2025年10月24日批准, 预计将在11月启动, 每月批发价为625美元, 不过病人费用可能低至25美元,
Approved on October 24, 2025, it is expected to launch in November with a $625 monthly wholesale price, though patient costs may be as low as $25 through Bayer’s support program.
该药物包含对昏睡、肝酶升高、怀孕损失和癫痫患者的癫痫发作的警告,应当避免葡萄汁。
The drug carries warnings for drowsiness, liver enzyme elevation, pregnancy loss, and seizures in those with epilepsy, and grapefruit should be avoided.
Lynkuet已获得几个国家的批准, 并加入Veozah, 成为美国少数对更年期炎热热症的非口服疗法之一。
Lynkuet is already approved in several countries and joins Veozah as one of the few non-hormonal oral treatments for menopausal hot flashes in the U.S.