(Reuters) - An advisory panel to the U.S. Food and Drug Administration on Thursday focused on heart safety and risk of hypoglycemia as it reviewed Danish drugmaker Novo Nordisk’s new ultra-ong-acting insulin degludec and considered whether to recommend its approval.
The panel began weighing the benefits and risks of the medicine, two days after FDA staff members said combined data from 16 studies suggest it may increase the risk of cardiovascular death, non-fatal heart attacks and strokes and unstable angina, compared to standard insulins.
Moreover, FDA staff reviewers had suggested degludec may offer no strong advantage in avoiding hypoglycemia -- dangerously low blood sugar levels that are a common side effect of insulin.
The stakes are high for Novo, the world’s largest insulin maker, because Wall Street deems the medicine capable of generating annual sales of $1.5 billion by 2016 if it is approved in the United States. It would compete with Lantus, Sanofi’s dominant long-acting insulin, which had sales last year of about $5 billion. U.S. drugmaker Eli Lilly is developing a similar medicine that is a few years behind in development.
In view of heart-safety concerns, the panel of outside medical experts is expected to vote on whether Novo Nordisk should be required to conduct a long and costly “outcomes” study of degludec to conclusively assess risk of heart attack and stokes in thousands of patients.
The company’s many completed studies of degludec did not enroll enough patients, or last long enough, to ascertain heart risks. Should an outcomes trial be required, the question is whether it must be conducted before the drug can be approved, or whether the FDA would allow it to be done after degludec reaches the market.
Novo officials on Thursday, speaking at the advisory-panel meeting in Silver Spring, Maryland, said they were committed to working with the FDA on a post-approval cardiovascular outcomes trial. The panel is expected to make its recommendations late in the afternoon on the outcomes trial, and whether to recommend degludec’s approval.
The negative commentary from FDA staff members on Tuesday sent shares of the Danish drugmaker sharply lower. It plans to sell degludec under the brand name Tresiba.
The European Medicines Agency last month recommended degludec’s approval, and it has already been approved in Japan.
Reporting By Ransdell Pierson; Editing by Kenneth Barry