Novo Nordisk (NYSE:NVO) shares ticked up 1% earlier this week after an advisory committee for the FDA voted to recommend that the company’s cardiovascular risk reduction claim be added to its Victoza (liraglutide) label.
The discussions among committee members involved data from the 9,300-patient Leader trial, which involved people with Type II diabetes at high risk of major cardiovascular events.
Nordisk first submitted the supplemental new drug application to the FDA in October last year. The company said it expects feedback from the regulatory watchdog in the 3rd quarter of this year.
The advisory committee voted unanimously, 19-0, in support of the claim that liraglutide is not associated with unacceptably high cardiovascular risk. On the claim that the company provided enough evidence to show that Victoza reduces cardiovascular risk, the committee voted 17-2.
“Cardiovascular disease is the number 1 cause of death for people with Type II diabetes, and today’s discussion is an important reminder that there is an unmet need to provide benefits beyond HbA1C control in this population,” Todd Hobbs, Nordisk’s VP & U.S. chief medical officer, said in prepared remarks. “The positive vote from EMDAC puts us 1 step closer to expanding our offering to reduce the risk of cardiovascular events in people with Type II diabetes.”