Novo Nordisk defers dream of expanding Victoza label after PhIII falls short

Novo Nordisk ($NVO) has hit a roadblock in its drive to expand the label for Victoza to cover use in Type 1 diabetics. The snag arose when Victoza failed to deliver hypoglycaemic benefit experienced by Type 2 diabetics in people with the other form of the disease in a Phase III trial.

Novo Nordisk Chief Science Officer Mads Krogsgaard

Victoza hit the primary endpoint of improved blood glucose control in the one-year, 1,398-peron trial, but the lack of the hoped-for hypoglycemic benefits has dissuaded Novo Nordisk from filing to expand the label. The Bagsværd, Denmark diabetes specialist will now go away and slice through the data before weighing up its clinical and regulatory options. It is possible the analyses will encourage Novo Nordisk to try again--the rate of severe hypoglycemia was numerically, but not statistically, lower in the treatment arm--but for now the plan is on hold.

"We are disappointed as we believed in the potential to provide people with Type 1 diabetes with a new treatment option, and we will continue to invest in new treatment options for this group of people," Novo Nordisk CSO Mads Krogsgaard Thomsen said in a statement. The setback leaves Novo Nordisk without a clear path forward for the expansion of Victoza--a blockbuster drug in Type 2 diabetes--into a new indication. Other R&D ventures in the company's diabetes empire are pushing ahead apace, though.

This week, Novo Nordisk got started on a Phase III trial of its oral diabetes treatment, the long-acting GLP-1 analogue, semaglutide. The late-phase program is a major undertaking. Novo Nordisk plans to run 6 safety and efficacy trials, plus one cardiovascular safety study, under the umbrella of its PIONEER development program. The first safety and efficacy trial is due to get underway early in 2016, with the remaining 6 studies going live later in the the year. By the end, Novo Nordisk expects to have tested the oral treatment in 8,000 Type 2 diabetics.

- read the Victoza release
- and the oral Phase III news

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