Reuters: Regulatory News: FDA panel to weigh heart safety of Novo's new insulin

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FDA panel to weigh heart safety of Novo's new insulin Oct 25th 2012, 16:49 LONDON | Thu Oct 25, 2012 12:49pm EDT LONDON Oct 25 (Reuters) - A U.S. expert panel assessing Novo Nordisk's ultra long-acting insulin degludec is to study its cardiovascular safety, raising a potential obstacle to approval in the world's top market. The Nov. 8 advisory committee will focus on the issue, "as meta-analyses of several clinical trials suggest an excess risk for cardiovascular events with this insulin over its comparators," according to a document posted on the Food and Drug Administration's website () The news will stoke concerns that degludec's benefits may not outweigh its potential risks in the eyes of U.S. regulators, who have already delayed a decision on the product. Any setback for degludec - which Novo plans to market under the brand name Tresiba - would be good news for rivals Sanofi and Eli Lilly. Degludec was recommended for approval by the European Medicines Agency last week but the U.S. decision is seen as pivotal, since this is where the bulk of future sales are expected to be generated. Degludec is central to Novo's aim of ending the dominance of Sanofi's product Lantus, the current market leader in the long-acting insulin market. Eli Lilly is also developing a rival drug that is a few years behind. Novo is the world's largest insulin maker and a key player in treating diabetes, a disease that is on the rise worldwide.

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