Novo Nordisk Fails to get FDA Approval for Much-Awaited Diabetes Drugs
Novo Nordisk said that the U.S. Food and Drug Administration (FDA) has asked the company to conduct additional clinical trials on the diabetes drugs Tresiba® and Ryzodeg®.
The company added that it received a Complete Response Letter Feb. 8, 2013. The letter is issued by the agency when it considers a given application and determines that its present form can't be approved and informs applicants of the changes that must be made.
Novo Nordisk said that it does not expect that it will be able to submit the required clinical trial data on cardiovascular effects of the drug during the year 2013.
"We are convinced that Tresiba® and Ryzodeg® offer significant benefits for people who require insulin. We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review," said Lars Rebien Sørensen, chief executive officer of Novo Nordisk in a news release from the company.
Both the drugs are approved in Japan, the EU and Mexico, Novo Nordisk said. The drugs had received a positive recommendation from the FDA advisory committee last year which led to greater anticipation of the drug approval, reports Forbes.
Novo Nordisk records major loss
The rejection of the drug by the FDA saw the market-value of the company lose about $15 billion, reports Bloomberg. Novo Nordisk needs to get Tresiba® in the market to compete with Sanofi's Lantus insulin.
Marketwatch reported that Novo Nordisk's shares fell by 14 percent in the European trading Monday.