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Novo seeks Victoza label expansion with fresh pediatric trial results

  • A top-selling diabetes drug from Novo Nordisk beat out placebo in reducing blood sugar in children with Type 2 diabetes, according to data published Sunday in the New England Journal of Medicine.
  • The Phase 3 study tested Novo’s Victoza in children aged 10 to 17. Patients on the GLP-1 agonist saw their average blood glucose levels decrease, while levels for study participants on the placebo arm increased. 
  • But the results weren’t an unqualified success, as Victoza also led to increased frequency of gastrointestinal side effects and did not help patients lose more weight than those given placebo over 26 weeks. The Danish drugmaker said it has submitted the data to U.S. and European regulators to expand Victoza’s label to include children 10 years and older.

Despite childhood obesity driving the prevalence of Type 2 diabetes higher in adolescents, treatment options remain limited, said William Tamborlane, the study’s lead investigator and a pediatrics professor at Yale University, in a statement.

Novo stated this trial, dubbed ELLIPSE, was the first Phase 3 study of Type 2 diabetic children completed in more than 10 years. The trial launched in 2012 and wrapped up last year, with 109 patients completing the study. By design, the study tested Victoza against placebo over a 26-week, double-blinded period, followed by a 26-week open-label extension and an additional 52-week off-treatment safety follow-up. 

First approved in 2010, Victoza (liraglutide) is an important drug for Novo, netting roughly $3.6 billion in global sales last year. But the drug’s share of the GLP-1 market has eroded over the past two years, as Eli Lilly’s Trulicity (dulaglutide) steadily posted prescription gains.

A pediatric label expansion could help Victoza grow further while Novo’s other GLP-1 agonist Ozempic (semaglutide) carves out its own share of the market. Ozempic launched in the U.S. in February 2018.

As of mid-April, Trulicity held a roughly 44% share of weekly new prescriptions for GLP-1 medicines, while Victoza’s has declined to just above 30%. Ozempic, meanwhile, has enjoyed steady growth over the past year, and now accounts for about 15% of the market, according to Iqvia data cited by the investment bank Cowen.

While Victoza hit the primary goal of Novo’s study, the drug also led to gastrointestinal adverse events that occurred more than twice as frequently as placebo. Minor hypoglycemia also occurred more than twice as frequently for Victoza patients.

These side effects, however, did not translate to higher discontinuation rates for the drug.

Additionally, the Victoza arm failed to show a statistically significant improvement in weight loss over placebo, as measured by the patients’ body mass index changes over 26 weeks.

The study’s authors calling it an “unexpected finding” in their discussion section.

“Although the mean difference in weight loss between these treatment groups was similar to that in trials involving adults, the relatively small number of patients in the current study and the fact that some children were probably still growing may explain the findings,” the researchers wrote.

During the open-label extension period, patients on the Victoza arm maintained the weight loss they experienced during the double-blinded period, while those on the placebo arm ended up gaining weight on average. 

Studies like ELLIPSE could help Victoza, but the drug’s window of exclusivity is approaching its end. Last month, Novo reached a settlement with Teva allowing generic entry beginning in March 2023.