Novo Nordisk 寻求林业发展局批准高剂量Wegovy,显示试验中平均体重下降20.7%。
Novo Nordisk seeks FDA approval for a higher-dose Wegovy, showing 20.7% average weight loss in trials.
Novo Nordisk已向林业发展局提出请求,请林业发展局批准对肥胖成人使用高剂量的减重药物Wegovy(7.2毫克西马格卢酸)。
Novo Nordisk has submitted a request to the FDA for approval of a higher dose of its weight-loss drug Wegovy (7.2 mg semaglutide) for adults with obesity.
72周试验的数据表明,较高剂量导致平均体重减少20.7%,而目前的剂量为2.4毫克,比17.5%减少2.4%。
Data from a 72-week trial showed the higher dose led to an average 20.7% weight loss, compared to 17.5% with the current 2.4 mg dose and 2.4% with placebo.
三分之一以上受较高剂量治疗的病人体重至少丧失25%。
Over a third of patients on the higher dose lost at least 25% of their body weight.
美国食品和药物管理局正在优先计划下审查该申请,预计将在1至2个月内作出决定.
The FDA is reviewing the application under a priority program, with a decision expected in 1–2 months.
欧盟、联合王国和其他区域也正在审查该药物,预计2026年初将作出决定。
The drug is also under review in the EU, UK, and other regions, with a decision expected in early 2026.