The FDA has denied approval of Sanofi and Lexicon’s drug, sotagliflozin, as an add-on to insulin therapy in the treatment of Type 1 diabetes. This decision comes just a few months after an FDA advisory panel failed to reach a consensus over whether the drug’s benefits outweigh its risks.
Sotagliflozin, works by inhibiting the proteins SGLT1 and SGLT2 to help regulate blood glucose levels and reduce the risk of weight gain. In other words, the drug inhibits the kidneys’ reabsorption of glucose. In a healthy adult, almost 200 grams of glucose go through the kidneys every day – and it all is reabsorbed. In diabetes, with the higher blood glucose levels the transporter proteins that do this are even more active, so that more glucose can be reabsorbed. Sotagliflozin blocks much of this activity, and people with type 2 diabetes taking it tend to lose weight (the increased urine glucose could account for a 200 calorie per day energy deficit) and have lower blood pressure, as well as having a substantial reduction in blood glucose levels. However, in people with Type 1 diabetes (or Type 2’s with low insulin production), the drug has been linked to the potentially life threatening condition of diabetic ketoacidosis (DKA).
According to endocrinologist, Dr. Mariela Glandt, while sotagliflozin and other SGLT1 and SGLT2 inhibitors can improve glycemic control, the risk of DKA is significant. “Therefore, the FDA’s decision doesn’t surprise me,” she said. “Each patient needs to be carefully evaluated before a deciding whether to treat with this class of drugs.”
On Friday, FiercePharma reported that “Lexicon shares plummeted by 40% as the news [of the FDA’s denial] broke but bounced back a little to be down 24% at 3:30 p.m.”
FiercePharma also reported that “the FDA’s Friday decision marks a setback for Sanofi, as the company could badly use the revenue from a new launch. The company was one of a few top drugmakers to post a sales decline last year. Jefferies analysts had predicted that the drug would generate peak annual sales of $1 billion. Sanofi’s shares were down about 2.5% on Friday afternoon.”