This was not a huge surprise because the FDA advisory committee did not seem to go wildly in their favor — half the panel voted against recommending approval. However, the members who voted in favor of approval were the endocrinologist clinicians who work closely with patients with diabetes. I really think that sotagliflozin should come to market for people with type 1 diabetes. We’ll see what the whole letter shows, but my advice is for the companies to convince the FDA that this drug provides more than a numeric benefit. You cannot just look at the HbA1c. They should also create a very careful risk evaluation and mitigation strategy (REMS) to conduct, in essence, phase 4 monitoring looking at what happens if approved.
I hope they can do both of those things: Convince the FDA that this drug really meets an unmet need and is good for patients with type 1 diabetes, and create a REMS that makes it safe in terms of follow-up. Perhaps roll this out for endocrinologists first, using it in a very specific way until they get more practice with it. I hope this doesn’t mean the end of it. I believe sotagliflozin is a good drug, and I hope the FDA lets the company make a better case for it.
Anne L. Peters, MD
Endocrine Today Editorial Board Member
Professor of Clinical Medicine
Keck School of Medicine, University of Southern California, Los Angeles
Disclosures: Peters reports various financial ties with Abbott, Becton Dickinson, Bigfoot, Boehringer Ingelheim, Dexcom, Eli Lilly, Janssen, Lexicon, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, Sanofi and Science 37.