FDA Fails to Approve Long-Awaited Diabetes Drug Manufactured by Novo Nordisk
Novo Nordisk says that the U.S. Food and Drug Administration has asked them to conduct further clinical trials on two diabetes drugs, Tresiba and Ryzodeb. Novo Nordis also added that it received a Complete Response Letter on February 8, 2013, which is issued by the FDA when it considers a given application and determines that its present form cannot be approved and informs applicants of the changes that need to be made.
Lars Rebien Sørensen, the CEO of Novo Nordisk, said in a statement:
"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."
Both Tresiba and Ryzodeb are already approved in Japan, the European Union, and Mexico. Last year the FDA advisory committee gave the drugs a positive recommendation, which had led to greater anticipation of the drug approval.
The rejection by the FDA instead has led to major losses for Novo Nordisk. Bloomberg reports that the market value of the company lost about $15 billion.