#AACE2021: Top 20-FDA Updates in Endocrinology, Diabetes, and Obesity

Video Transcription

Video Summary

In this video, several speakers from the FDA discuss updates on endocrinology, diabetes, and obesity. The session is moderated by Mata Bnyadi and includes talks from Drs. Naomi Laue, Laura Higginbotham, Brisa Kehoe, and Lisa Yanov. The speakers introduce themselves and their roles within the FDA. Dr. Laue discusses recent approvals for GLP-1 agonists, Lozempic and Trulicity, which are used to improve glycemic control in adults with type 2 diabetes and reduce the risk of major adverse cardiovascular events. Dr. Higginbotham talks about recent approvals for lipid-lowering drugs, including an oral non-statin drug for LDL-C reduction and a treatment for homozygous familial hypercholesterolemia. Dr. Higginbotham also discusses the first drug approval for pediatric obesity and the approval of a weight management treatment for patients with certain rare genetic conditions. The speakers also discuss recent approvals for insulin products, glucagon and glucagon analog products, and updates to the labels of existing drugs. The speakers highlight ongoing work in validating bone mineral density as a surrogate endpoint for fracture in osteoporosis drug trials, refining endpoints for cachexia and sarcopenia indications, and providing guidance for the treatment of chronic post-COVID symptoms. The session concludes with a Q&A session.

Asset Subtitle

Naomi Lowy, MD | Mahtab Niyyati, MD | Laura Higginbotham, MD, MPH | Theresa Kehoe, MD | Lisa Yanoff, MD

Keywords

FDA

endocrinology

diabetes

obesity

GLP-1 agonists

lipid-lowering drugs

insulin products