US Approval for Degludec Pending

A U.S. expert panel assessing Novo Nordisk’s ultra long-acting insulin, degludec, will study its heart safety, raising a potential obstacle to approval in the world’s top market. The panel will meet November 8 to 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

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 is expected to be generated. The news stokes 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.

Novo Nordisk CSO Mads Krogsgaard Thomsen said, however, that this focus was anticipated by the company and isn’t expected to hold up the planned launch of degludec and degludec plus.

"People get nervous ahead of an advisory committee meeting, because the outcome isn’t a given. But will we get the approval? Yes, I feel convinced we will," Mr. Krogsgaard said.

Degludec and degludec plus are both ultra-long acting insulins. Degludec plus is combined with fast-acting insulin aspart to give an instant effect, but also stabilize the blood sugar in diabetes patients over a longer timespan. The two insulin products have already been approved for the Japanese market, and have received a positive statement from the European Union regulator, which is expected to lead to a formal approval in the near future.

In recent years, the FDA Advisory Committee has routinely focused on cardiovascular risks in its evaluation of new insulin products, with one problem being that the occurrences of cardiovascular problems in trials are so rare that the data are insufficient for a comprehensive risk analysis.

"I see it as a likely outcome that the FDA grants the approval and asks us to subsequently perform a big cardiovascular risks study. That they will demand a risk study is performed before approval is granted I consider very unlikely," Mr. Mads Krogsgaard said.

Wall Street Journal, October 26