Novo Nordisk A/S (NVO)'s Insulin Tresiba Has Heart Safety Risks, FDA Says  
11/6/2012 8:20:23 AM

Novo Nordisk A/S (NOVOB)’s once-a-day insulin medicine Tresiba carries a higher heart risk than other diabetes treatments, U.S. regulators said. Novo’s shares dropped. Food and Drug Administration staff questioned whether more safety studies should be conducted on the product, also known as degludec, according to a report posted on the FDA website today ahead of a Nov. 8 meeting of agency advisers. Novo, the world’s largest insulin maker, designed the longer-lasting, higher-dose insulin to replicate the steady stream of the hormone that healthy people produce over 24 hours. Novo, based in Bagsvaerd, Denmark, is seeking to wrest market share from Paris-based Sanofi (SAN)’s best-selling Lantus insulin, which last year generated 3.92 billion euros ($5 billion) in revenue. Tresiba may produce about 9 billion kroner ($1.5 billion) in 2016 for Novo, according to the average of eight analysts’ estimates compiled by Bloomberg. Studies “consistently pointed to potential harm associated with the use of the insulin degludec products,” the FDA staff wrote in its report.