FDA Questions Novo's Phase 3 Data for Diabetes Drug

An FDA advisory panel released a preliminary review questioning results from a Phase 3 trial for Novo Nordisk’s IDegLira, an experimental diabetes treatment. The drug is a combination of Tresiba (insulin degludec), a long-acting form of insulin for patients with type 1 diabetes, and Victoza (liraglutide), which is an injectable medicine for improving blood sugar in type 2 diabetes patients.

Results of a late-stage study indicated this combination was a better diabetes treatment alternative when compared with Victoza or Tresiba alone, according to FierceBiotech. The agency’s assessment determined that this outcome was deliberately biased in favor of IDegLira in an effort to obtain regulatory approval.

IDegLira is projected to be an important source of revenue for Novo. Its selling point is that it offers diabetics a better way of managing blood sugar without succumbing to certain issues associated with insulin use like hypoglycemia or rare hypersensitivity reactions, which is why analysts pegged peak sales of this drug at an estimated $1 billion.

However, Reuters reported that the agency’s review determined that the benefit of combining both diabetes drugs into IDegLira came at the cost of a flexible dosing schedule as well as potentially exposing patients to the safety risks commonly associated with liraglutide and degludec.

The FDA’s assessment specified it didn’t find any new, undiscovered safety issues, but the advisory board believed this examination made it too difficult to interpret the clinical trial results.

Ultimately, this report was published ahead of a May 24 meeting where the advisory panel will gather to discuss if Novo’s product should get approval. A similar product made by Sanofi will also be under consideration at that time.