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Home Industry News Novo Nordisk’s obesity drug Saxenda approved in US

Novo Nordisk’s obesity drug Saxenda approved in US

2nd January 2015

Novo Nordisk has announced that its innovative new obesity drug Saxenda has been approved by the US Food and Drug Administration (FDA).

The therapy, which is the first once-daily human glucagon-like peptide-1 analogue for the treatment of obesity, has had its new drug application approved by the US regulator, ahead of a planned launch in the first half of 2015.

A marketing authorisation application for Saxenda has also been submitted to the European Medicines Agency and is currently still under review. The drug is intended as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity or who are overweight and have at least one weight-related comorbidity.

The US approval comes after the  FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 that the overall risk-benefit profile of Saxenda was favourable and supported approval for chronic weight management.

Mads Krogsgaard Thomsen, executive vice-president and chief science officer of Novo Nordisk, said: "Saxenda has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities."

This comes after the firm recently announced that its diabetes therapy Tresiba has been recommended for approval in a new paediatric indication by the European Medicines Agency's Committee for Medicinal Products for Human Use.ADNFCR-8000103-ID-801768351-ADNFCR

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