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Novo Nordisk’s diabetes drug liraglutide (Victoza) FDA approval delayed in US

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Wednesday, December 30, 2009, 13:57 This news item was posted in Industry category and has 1 Comment so far.

Victoza could be a potential block-buster to treat diabetes and obesity if approved, believes Novo

Liraglutide (Victoza), a potential block-buster drug by Novo Nordisk to treat type 2 diabetes and obesity, has been delaye approval in US, reports said.

US FDA, which was expected to given its opinion liraglutide (Victoza) by the year end, has delayed for a few more weeks.

However, a formal feedback on liraglutide (Victoza) is expected from US FDA within weeks, Novo Nordisk has stated.

Novo Nordisk filed its new drug application (NDA) for Victoza in May 2008, 19 months ago.

The European Commission granted marketing authorisation for liraglutide (Victoza) on 30 June 2009 for all 27 European Union member states and it is already on the market in Germany, the UK and Denmark.

Novo Nordisk has said liraglutide (Victoza) has potential to be a blockbuster drug, meaning annual sales of more than $1 billion.

Liraglutide (Victoza) will compete with Eli Lilly’s and Amylin Pharmaceuticals’ Byetta.

Victoza and Byetta both belong to the human glucagon-like peptide-1 (GLP-1) class of drugs that stimulate insulin release when glucose levels become too high.

GLP-1 drugs are also being developed by rival drugmakers, such as GlaxoSmithKline Plc  and Roche Holding AG.

In october, a comparative study with another anti obesity medication exenatide (Xenical) from Roche ,Novo Nordisk found liraglutide (Victoza) could help overweight patients to lose their excess weight by at least 10 pounds besides reducing the incidence of hypoglycaemia.

Novo Nordisk study involving 564 people found just five months of Liraglutide (Victoza) injections helped them lose 4.8 kilograms (10.6 pounds) to 7.2 kilograms of body weight, compared with 4.1 kilograms for those on exenatide (Xenical)  and 2.8 kilograms for those given placebo.

Victoza lowers blood glucose by stimulating the release of insulin when blood sugar levels are high and also by slowing gastric emptying.

Victoza reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.

Liraglutide (Victoza) is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, and in combination with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.

Liraglutide’s positive effect on lipid profile in patients with type 2 diabetes and  liraglutide’s ability to lower both HbA1c and weight without inducing hypoglycaemia versus that of the other active comparators in the LEAD programme including exenatide, glimepiride, rosiglitazone and insulin glargine. Each of the meta-analyses comprised 3,967 people with type 2 diabetes.

In the lipid meta-analysis, total cholesterol, low density lipoprotein, free fatty acids and triglycerides were all statistically significantly reduced from baseline with liraglutide over 26 weeks of treatment. Furthermore, total cholesterol and low density lipoproteins were significantly reduced with liraglutide treatment compared to rosiglitazone, glimepiride or insulin glargine.

In the meta-analysis evaluating efficacy on combined treatment targets of HbA1c and weight without hypoglycaemia, more patients in the liraglutide group reached HbA1c with no weight gain or hypoglycaemia than those on comparator treatments.

Based in Denmark, Novo Nordisk is a world leader in diabetes care. Novo Nordisk also has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy.

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One Response to “Novo Nordisk’s diabetes drug liraglutide (Victoza) FDA approval delayed in US”

  1. James Thrasher said on Friday, January 8, 2010, 3:53

    Exenatide is Byetta not Xenical

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