COPENHAGEN, Nov 9 (Reuters) - Denmark’s Novo Nordisk said on Friday it expected costs for additional cardiovascular studies of its new insulin degludec to amount to about 1.5 billion Danish crowns ($255.93 million) over the next six years.
The additional research will be carried out after an expert panel to the U.S. Food and Drug Administration (FDA) late on Thursday voted to recommend approval of the drug, but called for more studies due to potential cardiovascular risks.
Novo Nordisk’s Chief Science Officer, Mads Krogsgaard, told Reuters he expected the drug, which will be marketed under the brand Tresiba, could be launched in the United States in the first half of 2013.
Krogsgaard said Novo expects final approval of its new long-acting insulin degludec from the U.S. Food and Drug Administration (FDA) within the next two to 10 months. ($1 = 5.8610 Danish crowns) (Reporting by Shida Chayesteh)