- An FDA advisory panel on Tuesday voted unanimously to recommend approval for Novo Nordisk’s new combination treatment for adults with type 2 diabetes. IDegLira has been approved in Europe since 2014, but is marketed as Xultophy there.
- IDegLira is a once-daily, single-injection, fixed-dose combination of Novo’s basal insulin Tresiba and its GLP-1 agonist Victoza (liraglutide).
- Another meeting held today will consider whether to recommend approval for iGlarLixi, a competing combination diabetes drug from Sanofi.
Members of the advisory panel, who are independent, were able to look past a mixed review of IDegLira by FDA staff ahead of the vote. The preliminary review had raised questions about the drug’s trial design and practical benefit.
In particular, staff had questioned whether the combination product would add benefit even as it exposed patients to the risks of both drugs. Novo, however, hopes the fixed-dose combination will improve efficacy at lower doses, minimizing the side effect risk.
Barry Mennen, a practicing physician in the Washington, D.C. area, said he would welcome the combination of a GLP-1 agonist with basal insulin. “While many patients would benefit from this combination, there are a few patients groups that would seem to be the ones who deserve this as soon as it’s available,” Mennen said.
The FDA panel today considers whether to recommend Sanofi’s iGlarLixi, which combines Sanofi’s GLP-1 drug lixisenatide with Lantus. A preliminary review also questioned the drug’s utility and interpretability of its data, notes Reuters. One major difference with Sanofi's application is that the GLP-1 agonist component, lixisenatide, is not approved in the U.S., although it is approved in Europe.
Mennen thought iGlarLixi would likely benefit two populations in particular: patients with a long history of type 2 diabetes and have poor glucose control despite taking insulin, along with non-obese patients with insulin secretion defects.
Results of the panel vote for iGlarLixi will be available later. In both the case of IDegLira and iGlarLixi, the FDA does not have to follow the advice of the panel in making its final approval decision, although it usually does.