Dive Brief:
- Weeks after reporting positive Phase 3 results in diabetes patients for oral semaglutide, Novo Nordisk A/S followed up with another set of solid results, this time for the once-daily injectable version in a mid-stage study in obese patients without diabetes.
- The Danish drugmaker reported at the Endocrine Society's annual meeting that once-daily subcutaneous injections of semaglutide 0.4 mg helped patients lose 13.8% of body weight after 52 weeks.
- The trial tested semaglutide against placebo and Novo's other glucagon-like peptide-1 (GLP-1) agonist Saxenda.
Editor's Note: A previous version of this article mistakenly referred to Saxenda as Victoza.
Dive Insight:
In the Phase 2 trial, 83% of people getting semaglutide lost at least 5% of their body weight, compared to only 23% of those on placebo and 66% taking Saxenda (liraglutide).
Sixty-five percent of those patients taking semaglutide lost more than 10% of their body weight, compared with only 10% and 34% with placebo and Saxenda, respectively.
Novo's Victoza (liraglutide) has been the market-leading GLP-1 for the last several years for patients with diabetes. But the drug is also approved and sold under the name Saxenda to treat weight loss — although most sales still come from the diabetes indication.
Once-weekly injectable semaglutide is the follow-on product to Victoza and was approved in December for the treatment of type 2 diabetes under the brand name Ozempic.
Now Novo Nordisk is looking to extend that franchise. Traditionally the maker of only injectable drugs, the Danish drugmaker is bringing forward its first oral compound. The oral version of semaglutide has been closely watched and performing well in clinical trials. Novo reported positive topline results from a late-stage trial of the drug in February, noting it aims to file for approval with the Food and Drug Administration in 2019.
The diabetes drugmaker is looking to become a powerhouse in obesity treatments as well, calling it a keen area of focus on a recent earnings call.
Yet obesity has traditionally been a tough market to crack. Orexigen Therapeutics Inc. recently announced that it would file for chapter 11 bankruptcy after its obesity drug failed to ever take off.
Novo has the advantage of already having a trusted product in the indication. Expanding semglutide's reach could help bolster sales of the drug.
Still, it could be an uphill battle for Novo to make semaglutide regularly used as an obesity treatment for people without diabetes. Physicians are reluctant to prescribe drugs for obesity and are more inclined to recommend diet and exercise.
Other obesity drugs on the market have many uncomfortable side effects that deter patients and offer only minimal efficacy. Novo will have to prove that its treatment is both safe and can help people lose a significant amount of weight.
According to the statement from Novo, "the most common adverse events among people treated with semaglutide were dose-related gastrointestinal events." The trial also showed dose-related efficacy. Novo will need to show in late-stage trials that the side effects are worth the 13% efficacy the high dose demonstrated in this trial.
The drugmaker plans to pursue a Phase 3 program with the once-weekly injectable version of semaglutide.
"In line with our long-term commitment, we plan to start the STEP phase 3 clinical development program later this year to explore the potential of once-weekly semaglutide as a treatment for people with obesity," said Chief Scientific Officer Mads Krogsgaard Thomsen.
"This will also include the cardiovascular outcomes trial, SELECT, which will investigate the impact of semaglutide on the incidence of major adverse cardiovascular events compared to placebo in patients with established cardiovascular disease and either overweight or obesity."