COPENHAGEN Novo Nordisk said it was confident about the safety of new ultra long-acting insulin degludec, after news a U.S. panel is to examine its heart risks sent the Danish group's shares lower.
"They want to discuss whether there is a (cardiovascular) risk. Our assessment is that there is not," chief scientific officer Mads Krogsgaard told Reuters on Friday.
U.S. regulators have disclosed that a panel would focus on November 8 on the cardiovascular safety of the product, which Novo, the world's biggest insulin maker, plans to market as Tresiba.
"We are as optimistic as we have been all along. Had we seen anything significant that could be a big risk factor regarding degludec, we would have informed the market," Krogsgaard said.
Given concerns in the United States about the cardiovascular risk from new diabetes drugs, the U.S. panel's focus has made investors worried degludec could hit a roadblock in the world's biggest market.
Novo shares were down 3.3 percent at 1105 GMT.
"People are nervous that Tresiba might not be approved as a product," BankNordic senior portfolio manager Niels-Henrik said.
DNB Markets said in a note to clients it still believed the drug would be approved in the United States. "Novo will most likely have to carry out a post approval study to address cardiovascular safety," DNB said. "However, the risk of the FDA asking for additional studies ahead of approval has increased."
A document posted on the FDA's website said pooled analyses of several clinical trials suggested an excess risk for cardiovascular events with degludec over its comparators (tinyurl.com/dxlpvyq).
Any setback for degludec would be good news for rivals Sanofi and Eli Lilly.
While Novo's new insulin was recommended for approval by the European Medicines Agency last week, the U.S. decision is seen as pivotal since that is where the bulk of future sales were expected.
(Additional reporting by Ben Hirschler and Shida Chayesteh; Editing by Dan Lalor and Erica Billingham)