Novo Nordisk Dismayed By “Complete Response” Letter For Insulin Degludec
This article was originally published in Pharmaceutical Approvals Monthly
FDA is requesting data from a dedicated cardiovascular outcomes trial before approving the ultra-long-acting insulins Tresiba and Ryzodeg. News of the regulatory setback caused a 13% drop in the company’s stock price on Feb. 11.
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After widening the gap with competitors in the insulin market by a huge margin, Novo Nordisk is preparing to launch Tresiba and take a shot at the long-acting basal insulin market, a stronghold preserved by Sanofi globally. Will Tresiba firmly establish Novo Nordisk as the unquestionable insulin leader?
Novo Nordisk is evaluating new long-acting and quick-acting insulins in clinical trials as competitive pressure looks set to intensify in 2013 for its market-leading GLP-1 agonist, Victoza.
In briefing documents for the Nov. 8 panel review, FDA suggests the clinical trial data do not support Novo Nordisk’s assertion of a hypoglycemia advantage with its new long-acting insulin. Agency also raises concerns about a meta-analysis suggesting an increased cardiovascular risk.