GLP-1 analogue approved by FDA for CV risk reduction in diabetes

News - June 28, 2017

Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US FDA voted in favor of liraglutide, a human glucagon-like peptide-1 (GLP-1) analogue to treat diabetes. They unanimously agreed that the results of LEADER establish that use of liraglutide in patients with type 2 diabetes is not associated with excess cardiovascular risk and that the LEADER trial provides substantial evidence to establish that liraglutide 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes.

The LEADER trial involved more than 9,300 people with type 2 diabetes at high risk of major cardiovascular events. It was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of liraglutide (up to 1.8 mg) compared to placebo, both in addition to standard of care. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.

Liraglutide statistically significantly reduced the risk of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke by 13% versus placebo. The overall risk reduction was derived from a statistically significant 22% reduction in cardiovascular death with liraglutide treatment versus placebo and non-significant reductions in non-fatal myocardial infarction and non-fatal stroke.

Also, the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), issued a positive opinion on update of the EU label for liraglutide. The CHMP positive opinion for liraglutide is now referred to the European Commission, which grants approval in the EU, for final action on the proposed indication.

UPDATE Bagsværd, Denmark, 27 July 2017

The European Commission has approved an update to the Victoza® (liraglutide) EU label that expands the indication to reflect both improving blood sugar and cardiovascular (CV) events as integral parts of type 2 diabetes treatment.

Novo Nordisk news release (US) Update Novo Nordiks news release (Europe)

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