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Home Industry News Novo Nordisk research update

Novo Nordisk research update

20th November 2008

Novo Nordisk has said it has been informed the planned US Food and Drug Administration (FDA) advisory committee meeting has been rescheduled.

Set to decide upon approval of the company’s liraglutide, the gathering has been moved from March 2nd 2009 to either April 2nd or 3rd 2009.

The development is the latest progress in Novo Nordisk’s New Drug Application (NDA) to the FDA, which was originally made on May 23rd this year.

As a result of the meeting’s rescheduling, an action letter will be sent from the agency to the NDA – expected on March 23rd next year – following a ten-month review period.

In September, the FDA indicated it was most likely to extend the date of completing its assessment by a couple of months, adding it had notified Novo Nordisk of the timeline it is targeting.

The FDA’s advisory committee is a panel of independent experts which guides the agency upon regulatory decisions, with the meetings open to the public.

Liraglutide is a once-daily human Glucagon-Like Peptide-1 analogue, developed for the treatment of type two diabetes.

The drug works by stimulating the release of insulin only when glucose levels become too high and therefore inhibit appetite.

Based in Denmark, Novo Nordisk employs approximately 26,000 people in 79 countries.

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