- In a preliminary review of Novo Nordisk's type 2 diabetes drug IDegLira, FDA staff raised questions over the drug's trial design and practical benefit, Reuters reports.
- An advisory panel is scheduled to vote Tuesday on whether to recommend IDegLira for approval. The FDA doesn't have to follow any forthcoming recommendations, but usually does.
- IDegLira combines Novo's Tresiba (insulin decludec) with its other diabetes drug Victoza (liraglutide), a GLP-1 agonist.
Novo already won approval for IDegLira in the E.U., where it is marketed as Xutolphy. IDegLira is aimed at better controlling gylcemic control in adults with type 2 diabetes.
A combination drug could simplify diabetes treatment regimens with higher efficacy than the two products alone. However, as the FDA staff noted, combination drugs also expose patients to the side effects of both drugs at the same time.
The preliminary review also questioned how easily IDegLira's trial could be interpreted to support the drug's use. "There are really no robust empiric data to inform the question of whether a strategy that consists of starting multiple products at once will offer clinically meaningful long-term benefits to patients compared to a strategy that relies on a sequential add-on paradigm," the review said.
FDA staff also were concerned over limitations the combination product might have, compared to two separate products: "The enhanced convenience that derives from combining two products into one dosage form generally comes at the cost of loss of dosing flexibility."
However, no new safety issues were raised other than the already-known side effect profiles of the drugs.
Novo is hoping to compete with its diabetes rival Sanofi, which also has a GLP-1/basal insulin combination injection up for FDA review. A separate panel will review that drug, iGlarLixi, on Wednesday.