Wednesday, August 26, 2015 12:04:22 PM
Novo pulls blockbuster diabetes med Victoza off the Type 1 track
By Tracy Staton
Sorry, Victoza. Novo Nordisk ($NVO) has given up on the GLP-1 drug as a treatment for Type 1 diabetes, at least for now. A blockbuster in the Type 2 form of the disease, Victoza fell short in a new late-stage trial as an add-on to insulin therapy.
Higher doses of the drug did cut blood sugar levels and helped patients lose weight, but they also boosted the risk of hypoglycemia, Novo said. The lowest dose failed to beat placebo at controlling blood sugar or triggering weight loss.
Together with the results of a previous Type 1 trial, the latest data underwhelmed Novo execs. The company "does currently not intend to submit an application to expand the label of Victoza for use in type 1 diabetes," Novo said in a statement.
Novo's Mads Krogsgaard Thomsen
"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," said Mads Krogsgaard Thomsen, Novo's EVP and chief science officer.
The company will dig around in the clinical data, analyzing it for potential avenues for future study or regulatory moves.
Novo markets insulins commonly used to treat Type 1 diabetes, an autoimmune disorder that is typically diagnosed in childhood, and has been testing Victoza for years as a potential add-on therapy. Phase II trials had been successful enough to prompt the late-stage studies.
In Type 2, Victoza is typically adopted before insulin, as an add-on to the standard therapy metformin. Despite new competition in the GLP-1 field this year, Victoza brought in about $1.3 billion for the first half, up 22% ex-currency effects. And Novo has had success expanding the franchise in other areas. The active ingredient, liraglutide, recently won FDA approval as a weight-loss drug under the brand name Saxenda. A combo version of the med, pairing liraglutide with Novo's new insulin, Tresiba, recently won approval in Europe.
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