In part 4 of this Exclusive Interview, Dr. Todd Hobbs talks with Diabetes in Control Publisher Steve Freed during the ADA meeting in San Diego, California, about the GLP-1 cardiovascular trials and the significance of the LEADER study.
Dr. Todd Hobbs is Vice President and Chief Medical Officer for Novo Nordisk in North America, where he leads the organization’s focus on the implications of diabetes for the patient, healthcare system, and healthcare professionals. He provides overall medical guidance to Novo Nordisk’s diabetes and obesity-related projects.
Transcript of this video segment:
Steve: What about your GLP-1? Are you in the process of doing cardiovascular studies?
Dr. Hobbs: We have several ongoing. Victoza, which is approved, we did the LEADER study, which was at last year’s ADA in New Orleans. We had filed that with the FDA to be added into the label and we have an advisory committee meeting set to discuss that cardiovascular outcomes trial. SUSTAIN-6 is our semaglutide, weekly GLP-1 injection, that is actually filed with the FDA now as well. SUSTAIN-6 is part of that package. We are not asking for a pre-approval claim to say we benefit, but the data did show that there was a reduction in the MACE endpoint and it did have benefits like LEADER did. That data is included in the submission for that drug. Then also we have an oral GLP-1 that is in phase III, and that has the same type of pre-approval cardiovascular outcomes trial. We want to make sure that even though it’s the same semaglutide molecule just in a different delivery via oral route, there could be changes in the way it affects many things, including cardiovascular risk, so the FDA has discussed with is we will do a separate cardiovascular outcomes trial for the oral form of semaglutide. That’s ongoing.
Steve: You’re actually doing a separate study even though it’s the same drug.
Dr. Hobbs: Exactly. We will see in a year or so when the results are available if that’s enough to satisfy the FDAs concerns or not and I’m sure we’ll be presenting that in a year or two.
Steve: What is the significance of the LEADER trial today?
Dr. Hobbs: It is significant. When you look at the debate over diabetes drugs and initially saying that they should not increase the harm to patients who already have a CV risk. Now to say we have a reduction in CV risk by 13%; all-cause mortality, 15% and we are effectively treating their diabetes with a robust agent, lowering their weight, etc., that is a nice message for Victoza. At this point we can say that we have the only GLP-1 agent that has shown a benefit. There have been a few other agents, both short-acting and weekly, that recently announced that they were neutral. It is rather unique that perhaps it is related to the molecule itself, but liraglutide or Victoza ,is the only GLP-1 agent that has shown benefit at this point.