Narrow FDA advisory panel vote for Jardiance cardiovascular indication
A US Food and Drug Administration advisory committee yesterday voted 12-11 that substantial evidence exists to establish that Jardiance (empagliflozin) reduces cardiovascular (CV) death in adults with type 2 diabetes (T2D) and established CV disease.
Jardiance, which is marketed by family-owned German pharma major Boehringer Ingelheim and US peer Eli Lilly (NYSE: LLY), is the only oral T2D medicine shown in a clinical trial to reduce the risk of CV death, the companies stated.
The drug is an oral, once daily, highly selective sodium glucose co-transporter 2 (SGLT2) inhibitor approved for use in Europe, the USA and other markets around the world for the treatment of adults with type 2 diabetes.
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