Novo Nordisk (NYSE: NVO) Receives FDA Approval for Victoza Print E-mail
Monday, 25 January 2010 20:20

Novo Nordisk (NYSE: NVO) Receives FDA approval for Victoza (liraglutide) as once-daily injection for Type 2 diabetes. Below is the former FDA Calendar entry for NVO / Victoza and the approval also includes several post-marketing requirements.

On 9/23/09, NVO announced the delay until 4Q09 of formal feedback from the FDA for its pending Victoza (liraglutide is a once-daily human GLP-1 analogue) NDA seeking U.S. marketing approval for the treatment of type 2 diabetes in adults. On 7/3/09, NVO announced European Commission marketing authorization for liraglutide in the treatment of type 2 diabetes in adults. On 1/20/10, NVO announced marketing approval for liraglutide in Japan.

The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending. Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors.

Panelists were split, voting 6-6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8-5 in favor of the drug's cardiovascular safety profile. On 12/30/09, NVO reported that it expects FDA feedback within weeks for liraglutide and would provide an update on the regulatory process along with financial results on 2/2/10 if formal feedback is not received from the Agency by that time.

Disclosure: No positions




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