At long last, Novo Nordisk has been given regulatory approval across the Atlantic for its diabetes drug Victoza.
The US Food and Drug Administration has given the green light for Victoza (liraglutide), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes. It can now be sold as a monotherapy, as second-line treatment and in combination with other oral diabetes drugs.
However the approval comes with a boxed warning for the risk of thyroid c-cell tumours. In preclinical testing, Victoza caused these tumours in rodents and even though there have been no reported cases of medullary thyroid carcinoma in patients treated with Victoza, the FDA has decreed a risk cannot be ruled out. Therefore the drug is contraindicated in patients with a personal or family history of MTC or multiple endocrine neoplasia syndrome type 2.
The approval also comes with several post-marketing requirements, including a cardiovascular study to examine safety of Victoza in a higher risk population, in line with new FDA standards for diabetes drugs implemented in December. Novo will also have to carry out a five-year study to “evaluate thyroid and other cancer risks as well as risks for hypoglycaemia, pancreatitis, and allergic reactions”, the agency noted.
Despite all this, the approval is good news for Novo and chief executive Lars Rebien Sorensen is an important milestone following the recent approval in Japan and ongoing successful launch in Europe. The company expects to introduce Victoza in the US market “within weeks”.
