FDA approves diabetes drug developed by Novo Nordisk
On Friday, the US Food and Drug Administration gave green signal to drugmaker Novo Nordisk's diabetes drug Tresiba. For two years, the agency had been rejecting a form of insulin that works longer.
The agency also gave green signal to the company's Ryzodeg, which is an injection that is a combination of Tresiba and a man-made form of insulin. Novo Nordisk is the world's leading maker of insulin, which is a hormone usually produced by the pancreas that assists the body in using glucose for energy.
According to Thomson Reuters Cortellis, Tresiba is already available in 30 countries, and by 2020, analysts forecast annual sales of $2.4 billion.
According to Soren Lontoft Hansen, senior analyst at brokerage firm Sydbank, "The U.S. market for basal insulin represents over 80 percent of the global market. We expect a positive price reaction on Monday between 5 percent and 10 percent".
In 2013, the FDA had rejected Tresiba. The agency had asked for more information on risks of heart problems from the drug's use. According to reports, on Friday, US-listed shares of Novo Nordisk dropped 10 cents to close at $54.93.
According to Todd Hobbs, chief medical officer for Novo Nordisk in North America, there could be a gap of as much as 42 hours between doses, when it comes to diabetics who use Tresiba as compared to those who take Levemir (with 18 to 24 hours) for current long-lasting insulin of the company.
Novo Nordisk said that during the first quarter next year, it is looking forward to launch Tresiba in the United States.
Novo Nordisk is a Danish multinational pharmaceutical company headquartered in Bagsværd, Denmark, with production facilities in seven countries, and affiliates or offices in 75 countries.
Novo Nordisk manufactures and markets pharmaceutical products and services.
"The U.S. market for basal insulin represents over 80 percent of the global market," said Soren Lontoft Hansen, senior analyst at brokerage firm Sydbank. "We expect a positive price reaction on Monday between 5 percent and 10 percent."