(Reuters) - The United States Food and Drug Administration on Friday (Sept 25) approved Danish drugmaker Novo Nordisk's diabetes drug Tresiba, two years after rejecting the long-acting form of insulin.
The regulator also approved the company's Ryzodeg, an injection that combines Tresiba and a fast-acting manmade form of insulin.
Novo Nordisk is the world's No. 1 maker of insulin, a hormone normally produced by the pancreas that helps the body use glucose for energy.
The approvals include warnings that Tresiba and Ryzodeg should not be used in patients who have high levels of the chemical ketone.
Tresiba is already being sold in 30 countries, and analysts expect annual sales of $2.4 billion (S$3.4 billion) by 2020, according to Thomson Reuters Cortellis.
"The U.S. market for basal insulin represents over 80 per cent of the global market for basal insulin, which underlines the importance of Tresiba," said Soren Lontoft Hansen, senior analyst at brokerage firm Sydbank.
"We expect a positive price reaction on Monday between 5 per cent and 10 per cent." U.S.-listed shares of Novo Nordisk fell 10 cents to close at $54.93 on Friday.
Hansen said the U.S. approval sets the stage for Novo Nordisk to compete against long-acting insulins Lantus and Toujeo sold by rival Sanofi SA.
As an ultra-long acting product, Tresiba is sold at a premium to other insulins, but a spokesman for Novo Nordisk said the company has not yet determined a U.S. price for the new insulin.
Novo Nordisk said it expects to launch Tresiba in the United States during the first quarter of 2016. The company spokesman said a launch target for Ryzodeg has not yet been determined.
Analysts were confident that the FDA would approve Tresiba, considered a future blockbuster for the company, after the company submitted new test results to the agency earlier this year.
The FDA had declined approval in 2013, asking for more data on risks of heart problems from using the drugs.
Novo Nordisk earlier on Friday said its new experimental once-weekly diabetes drug, semaglutide, was successful in a late-stage study.