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FDA backs Novo’s diabetes drug for cardiovascular efficacy

pharmafile | June 21, 2017 | News story | Research and Development Novo Nordisk, Victoza 

Good news for Novo Nordisk as the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommends that data from a recent study into Victoza’s (liraglutide) efficacy in reducing cardiovascular risk should be included on the drug’s label.

The data was generated through a study examining Victoza’s effects in combination with standard care in type 2 diabetes patients at risk of major cardiovascular events over a period of 3.5 to 5 years. It was found that the GLP-1 receptor was able to reduce the risk of cardiovascular death, as well as non-fatal heart attacks and strokes by an overall 13% versus placebo – this includes a 22% reduction in cardiovascular death specifically.

As a result of the findings, the EMDAC voted 17-2 in favour of including them on the label. The decision puts Victoza in a position of strength – with proven efficacy in reducing cardiovascular risk, the drug will have an edge over other diabetes treatments, given that half of deaths from the disease are caused by such risks.

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“Cardiovascular disease is the number one cause of death for people with type II diabetes, and [the Committee’s] discussion is an important reminder that there is an unmet need to provide benefits beyond HbA1c control in this population,” said Todd Hobbs, Vice President and US Chief Medical Officer of Novo Nordisk. “The positive vote from EMDAC puts us one step closer to expanding our offering to reduce the risk of cardiovascular events in people with type II diabetes.”

Matt Fellows

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