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FDA panel backs CV claims for Novo Nordisk's Victoza

LEADER trial shows the diabetes treatment reduces risk of cardiovascular death by 13%

Novo Nordisk

Novo Nordisk has been buoyed by an FDA advisory committee vote that said data from a study of Victoza's efficacy in reducing cardiovascular risk should be included on the drug's label.

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 17-2 in favour of including the results of the LEADER trial of GLP-1 receptor agonist Victoza (liraglutide) in type 2 diabetes patients at high-risk of developing cardiovascular disease.

LEADER looked at Victoza’s effects in combination with standard care in diabetics at risk of major cardiovascular events over a period of 3.5 to five years and found that the drug was able to reduce the risk of cardiovascular death, as well as non-fatal heart attacks and strokes by an overall 13% versus placebo, which included a 22% reduction in cardiovascular death.

"Cardiovascular disease is the number one cause of death for people with type II diabetes, and [the EMDAC's] discussion is an important reminder that there is an unmet need to provide benefits beyond HbA1c control in this population," said Todd Hobbs, Novo Nordisk's chief medical officer.

"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 2 diabetes."

Victoza is the second drug to get a recommendation for improving cardiovascular outcomes in type 2 diabetics after Eli Lilly and Boehringer Ingelheim's SGLT-2 inhibitor Jardiance (empagliflozin), which had the data from the EMPA-REG trial added to its label in 2015. Merck & Co failed to win FDA approval for a similar claim for its DPP-4 inhibitor Januvia (sitagliptin) in April.

Having cardiovascular benefits on the label can confer a significant advantage to antidiabetic medications, as around half of diabetes-related deaths are caused by heart disease.

The vote is also a boost for Novo Nordisk as it strives to stay at the top of the diabetes market amid increasing competition to once-daily Victoza from Eli Lilly, which has been gaining ground with its once-weekly Trulicity (dulaglutide) GLP-1 drug, which saw sales almost quadruple last year to $925m.

The Danish drugmaker filed its own once-weekly drug semaglutide towards the end of last year, but in the near-term is still reliant on growth from Victoza, which was its biggest product last year with sales of more than 20bn krone (around $3bn).

EvaluatePharma has predicted that semaglutide will firm up its franchise with sales of $2.2bn by 2022, keeping Novo Nordisk at the top of the market with diabetes sales of almost $18bn in that year, ahead of Lilly with around $8bn in sales.

Article by
Phil Taylor

21st June 2017

From: Regulatory

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