Another Option for Obesity on the Horizon – Positive Vote from FDA’s Advisory Committee on Novo Nordisk’s Saxenda
Twitter summary: Exciting positive vote for #liraglutide #emdac on possible new therapy for #obesity! Plus, our favorite open public hearing yet.
Yesterday on September 11, the FDA Advisory Committee voted a very positive 14-1 in favor of approving Novo Nordisk’s liraglutide 3.0 mg as a treatment for obesity. Liraglutide is a GLP-1 agonist that is currently available at lower doses as Victoza for type 2 diabetes, although this new indication and dose will be marketed as Saxenda. This vote followed a packed day of presentations at the FDA’s Advisory Committee meeting on the drug’s efficacy and clinical safety – you can read some of our live updates on our Twitter @diaTribeNews here. However, in our view, the best part of the day was the high turnout at the Open Public Hearing, where a record 21 speakers shared their thoughts and experiences about the therapy, with the vast majority in favor of approval. It was a great day for patient advocacy and a model for how the FDA can work more closely with advocates in the future.
Dan Wright's testimony was particularly affecting, which Diabetes Hands Foundation President Manny Hernandez caught on video – the talk was perhaps the high point of the day in driving the patient message home. Manny himself gave a wonderful talk about the patient views of TuDiabetes and EsTuDiabetes, while diaTribe managing editor Nancy Liu shared valuable statistics and experiences from patients in the dQ&A community on the challenges of managing diabetes and weight. Patient representative Ms. Rebecca Killion (speaking for the ADA) also commented on the “inseparable” nature of diabetes with obesity – and the frustration of "A1c down? Weight is up...".
Dr. Lee Kaplan of Massachusetts General Hospital was on hand to note the diversity of patients within the obese population (and the power of “super-responders” to a drug). diaTribe senior editor Adam Brown discussed worrying obesity stats, focusing on the growth of severe obesity that is often under-recognized. Our own Editor-in-Chief Kelly Close spoke on the huge problem of prediabetes and emphasized the need for patients and health care providers to have more alternatives to prevent type 2 diabetes. Of course there were lots of valuable contributions from medical professionals and others serving as advocates, which include Joe Nadglowski and Ted Kyle of the Obesity Action Coalition, Dr. Sean Wharton of Toronto East General Hospital and the Wharton Medical Clinic, Dr. George Grunberger representing AACE.
We’ll be back soon with more on the day’s discussion on efficacy and safety. Generally, we were excited to learn that the panel did not feel that a new cardiovascular trial would be required for the 3.0 mg dose of liraglutide, and the ongoing LEADER trial studying Victoza (liraglutide 1.8 mg) would be enough data required for cardiovascular risk. However, the FDA still has quite a bit to consider regarding post-marketing data and labeling questions before (hopefully) approving the drug. Stay tuned! – NL