The review comes ahead of a May 24 meeting of an FDA advisory panel that will discuss the drug and make recommendations as to whether it should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does. The drug combines Novo's drug Tresiba, known also as insulin degludec, with its GLP-1 agonist Victoza, known also as liraglutide. The company is seeking FDA approval for the combination product, IDegLira, to improve glycemic control in adults with type 2 diabetes. The drug was approved in Europe in 2014 under the brand name Xultophy.
On May 25 the advisory committee will consider a similar drug, Sanofi SA's iGlarLixi, which combines the company's experimental GLP-1 agonist lixisenatide with its insulin treatment Lantus, also known as insulin glargine. The two companies' products would be the first to combine a GLP-1 and a basal insulin in a single injection. The idea is to treat patients earlier with a combination drug rather than waiting for patients to lose control of their blood sugar on one drug before moving to another. In its review of Novo Nordisk's drug, the FDA said, "The enhanced convenience that derives from combining two products into one dosage form generally comes at the cost of loss of dosing flexibility."
Employees stand in the insulin production plant of Danish multinational pharmaceutical company Novo Nordisk in Chartres, north-central France
The FDA reviewers found no new safety issues with IDegLira that were not already known for degludec and liraglutide but said, "It is important to note that use of IDegLira would expose patients to safety risks associated with both products." The reviewers also said the use of IDegLira allows for lower doses of liraglutide than have been proven efficacious while incurring safety risks associated with liraglutide use. The reviewers said there were limitations with the clinical trials that make the results difficult to interpret.
Diabetes is a chronic metabolic disorder characterized by abnormally high blood sugar levels that can lead to blindness, heart disease and other serious conditions. Lixisenatide was approved by regulators in Europe and Japan in 2013 and is sold under the brand name Lyxumia. Sanofi licensed lixisenatide from Denmark's Zealand Pharma A/S.