Published October 19, 2012
Shares of Novo Nordisk (NVO) climbed more than 1% to a 52-week high on Friday after the drug company said its new long-lasting insulin diabetes drug degludec got the nod from European Union health regulators.
The company, which hit regulatory delays in the U.S. earlier this year, also said it has presentations to the Food and Drug Administration in early November.
Tresiba, which is the intended brand name for Novo’s degludec, is a part of Novo’s efforts to steal market share from leader Sanofi (SNY).
The injectable drug, which is in a growing area of long-acting insulin products, is expected to launch in several European markets early next year, pending final approval.
Recommendations by the European agency’s Committee for Medicinal Products for Human Use are typically adopted by the European Commission. Novo said it anticipates approval within the next two months.
“This gives us confidence, that we soon can make Tresiba and Ryzodeg available to many people with diabetes in Europe,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Novo also won approval for Ryzodeg, a product that combines degludec with insulin aspart. Ryzodeg is expected to launch in certain markets one year after Tresiba.
Tresiba has already been approved in Japan, while Ryzodeg remains under review.