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司美格鲁肽新适应症获EMA支持

Simeglutide's new indication has been supported by EMA.

Breakings ·  Jul 27 08:08

Novo Nordisk announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and agreed to update the label of its once-weekly subcutaneous injection weight-loss therapy Wegovy (2.4 mg semaglutide, simeglutide) to reflect data from the SELECT cardiovascular outcomes trial. The trial has demonstrated that for adults diagnosed with cardiovascular disease and overweight or obesity (initial body mass index [BMI] ≥27 kg/m2) and without diabetes, Wegovy can reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. According to the positive opinion of the CHMP, Novo Nordisk expects to implement the labeling update in about one month. (Translated by Wuxi AppTec)

The translation is provided by third-party software.


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