FDA Clears Novo Nordisk Diabetes Drug
September 25 2015 - 5:40PM
Dow Jones News
Novo Nordisk A/S has received Food and Drug Administration
approval for the diabetes treatment Tresiba, a long-acting insulin
product that was rejected in 2013.
Novo Nordisk expects a U.S. launch for Tresiba in the first
quarter of 2016.
The FDA also approved Ryzodeg, a coformulation of Tresiba and
another Novo Nordisk insulin.
After Tresiba was approved in Japan and Europe, the FDA rejected
it in February 2013 over heart-safety concerns and demanded a new
trial looking at cardiovascular effects. In March, the company
decided to resubmit its application following an interim analysis
of a cardiovascular outcomes trial.
In July, Novo Nordisk decided to halt Tresiba sales in Germany
following a pricing dispute with the National Association of
Statutory Health Insurance Funds.
The FDA said Friday that Tresiba's efficacy and safety were
evaluated in four 26-week and two 52-week active-controlled
clinical trials involving 2,702 participants.
In a test known as HbA1c, blood-sugar reduction was in line with
reductions achieved with other, previously approved long-acting
insulin products, the FDA said.
Novo Nordisk also said it submitted a New Drug Application for
Xultophy, a once-daily single-injection combination of Tresiba and
the company's diabetes drug Victoza.
Write to Josh Beckerman at josh.beckerman@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
September 25, 2015 17:25 ET (21:25 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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