Novo Still Expects FDA Approval for Liraglutide

Novo Nordisk

Despite a split ruling on the safety of a new diabetes drug by the U. S. Food and Drug Administration's (FDA) advisory panel, Novo Nordisk says it still expects to get the agency's approval for Liraglutide.

Friday, shares for the world's biggest insulin maker dropped by as much as 13%, after the FDA panel gave a split ruling on whether thyroid tumours found in Liraglutide tests conducted on rats and mice, will prevent sales of the drug for human consumption.

While, government experts are of the opinion that the Danish drug manufacturer's experimental drug does not come with heart risks, its possible links to tumours is 'worrisome'.

Novo has asked FDA for approval of liraglutide, its injectable drug for treating millions of patients suffering from Type 2 diabetes, which disrupts the body's ability to break down carbohydrates and control blood sugar. Even though Novo touts the drug's ability to control blood sugar levels, even as it reduces weight, compared to many other drugs that cause weight gain, panelists have voted 6 to 6 on whether to approve the drug or not, as there is evidence it caused cancerous thyroid tumours in rats and mice tested with it.

Belonging to the GLP-1 family of diabetes medications, including Byetta, marketed by Eli Lilly and Amylin Pharmaceuticals, the two drugs help control blood sugar by increasing insulin production and slowing the body's absorption of sugar. However, Novo's drug enjoys an advantage over Byetta, as it requires one injection per day, instead of two.

Amongst the first drugs FDA's panel of diabetes experts have voted on, since new safety guidelines for diabetes treatments were issued by the agency, last year, if approved, Liraglutide will be marketed under the name Victoza. A decision is expected in the coming weeks.

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