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Novo’s degludec backed by FDA
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RegulatoryDenmark

Novo’s degludec backed by FDA

12.11.2012 - An FDA panel says that Danish Novo Nordisk’s new recombinant insulins pose certain risks but still approves them. The benefit is evident, it states.

A federal advisory panel backed the long-acting insulin degludec by Novo Nordisk A/S. However, it said the company should conduct a post-approval study to address concerns about a possible increased risk of cardiovascular events such as heart attacks and strokes. The decision was not unanimous. Four of the 12 committee members voted against the approval. The proponents felt that the benefits outweigh the risks. The products were Tresiba insulin Degludec, a long-acting insulin analogue, and Ryzodeg, a combination of 70% insulin Degludec and 30% Novo Nordisk's NovoLog (insulin aspart). When balanced with comparators, both drugs are very efficient at reducing hypoglycemia.

The Danish company has already prepared a trial to meet FDA criteria. It has designed as a five-year cardiovascular outcomes trial that would enrol 7,500 type II diabetes patients. The FDA's endocrinologics and metabolic drugs advisory panel is composed of non-FDA medical experts. In Europe, insulin degludec recently received market approval. Recombinant insulins are used to treat diabetes, a disease that is characterised by the body's inability to either make or properly use insulin. Some manufactured insulins – such as Lilly’s Humulin or Novo Nordisk’s Novalin – have already lost patent protection. Others, like Humalog (Eli Lilly), Levemir and Novalog (both Novo Nordisk), and three of Sanofi’s four patents on Lantus , will follow in the next two years. With the advent of recombinant insulin biosimilars, Novo Nordisk is wise to develop a successful successor in the market.

© eurobiotechnews.eu/ml

http://www.european-biotechnology-news.com/news/news/2012-04/novos-degludec-backed-by-fda.html

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