The US Food and Drug Administration yesterday approved Danish insulin giant Novo Nordisk's Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults, after safety concerns delayed the agency's decision by about 10 months. Last April, a panel of FDA experts were split, voting six to six on whether the agency should clear Victoza in the face of evidence it caused cancerous thyroid tumors in rats and mice.
"The US approval of Victoza represents a major advancement in the treatment of type 2 diabetes and is an important milestone for Novo Nordisk that follows the recent approval in Japan and the ongoing successful launch in Europe." says Lars Rebien Sorensen, president and chief executive of the firm. "We are convinced that Victoza will prove to be a valuable treatment option for people with type 2 diabetes in the USA. The ability of Victoza to substantially improve glucose control with a low risk of hypoglycaemia creates an opportunity for more patients with type 2 diabetes to achieve their individual treatment goals,' he added, noting that Novo Nordisk expects to introduce the product in the US market 'within weeks.'
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