COPENHAGEN (Reuters) - Shares in Novo Nordisk (CO:NOVOb) rose as much as 5 percent on Monday after the U.S. Food and Drug Administration (FDA) approved the diabetes drug Tresiba, allowing the Danish drugmaker to prepare its largest ever drug launch.
The FDA's decision late on Friday came two years after it had rejected the long-acting form of insulin. The world's largest insulin maker expects to launch Tresiba in the United States during the first quarter of 2016.
"This will be Novo's largest drug launch ever and we believe it is very well prepared," Nordea analyst Michael Novod wrote in a note to clients.
By 0307 EDT shares in Novo Nordisk were up 1.8 percent to be one of the best performers among top European shares (STOXX). They also outperformed a flat Copenhagen main index (OMXC20CAP).
Novo Nordisk shares are on track for their best day in 6 months and stock is now among European bluechips trading above levels last seen before the global equity rout that began on Aug. 21
Tresiba is already sold in 30 countries, and analysts expect annual sales of $2.4 billion by 2020, according to Thomson Reuters Cortellis.
The U.S. approval sets the stage for Novo Nordisk to compete against long-acting insulins Lantus and Toujeo sold by rival Sanofi SA (PA:SASY), said Sydbank analyst Soren Lontoft Hansen.
As an ultra-long acting product, Tresiba is sold at a premium to other insulins.
"The labeling did come out largely as we had expected. We intend to launch Tresiba in the U.S. market with a moderate premium," said Chief Executive Lars Rebien Sorensen at a conference call with analysts on Monday.
FDA also approved the company's Ryzodeg, an injection that combines Tresiba and a fast-acting form of insulin.
