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Novo Nordisk A/S Seeks US And EU Approval for Degludec Insulin PDF Print E-mail
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Friday, 30 September 2011 00:30
Danish drugmaker Novo Nordisk (NOVOb.CO) has filed applications for approval in Europe of its ultra long-acting insulin Degludec and insulin combination analogue DegludecPlus and aims to file applications with U.S. regulators soon.

These new insulins have been developed for the treatment of people with type 1 and type 2 diabetes, Novo Nordisk said in a statement.

"We are looking forward to making these new insulins available to diabetes patients as soon as possible after completion of the regulatory processes," chief science officer Mads Krogsgaard Thomsen said in the statement.

Novo Nordisk expects to file two new drug applications for Degludec and DegludecPlus to the U.S. Food and Drug Administration within two weeks, Novo Nordisk said.

The filings are based on results from clinical trial programmes which involved nearly 10,000 type 1 and type 2 diabetes patients, the company said.

Data from the trials have shown Degludec to effectively lower blood glucose levels, it said.

 (Reporting by John Acher; Editing by Elaine Hardcastle)

 

 
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