Not all 1.3 million American adults with type-1 diabetes will be eligible to receive Sotagliflozin.
The U.S. Food and Drug Administration (FDA) advisory panel, was reportedly divided over whether to recommend the approval for a type-1 diabetes treatment developed by biopharmaceutical firms – Lexicon Pharmaceuticals Inc. and Sanofi.
Apparently, on Thursday, the advisory panel voted eight-eight when asked to assess the oral medicine – Sotagliflozin, an add-on to insulin therapy. For the record, Insulin has been used to treat diabetes for decades, however side effects like hypoglycemia (a condition in which blood sugar falls to extreme low levels) and weight gain are rather commonplace.
Pablo Lapuerta, Chief Medical Officer, Lexicon Pharmaceuticals Inc., was reportedly quoted stating that Sotagliflozin was tested in two doses, and it could help maintain & manage glucose levels while reducing the risk of hypoglycemia. Lapuerta adds that the drug is not for newly diagnosed type-1 diabetes patients, mainly children & young adults, for whom the priority is to recognize their optimal insulin level.
Reportedly, at the meeting, patients who were part of the trials supported the effectiveness of the drug, however, the FDA staff highlighted the risk of diabetic ketoacidosis (DKA), leaving the advisory panel divided over whether benefits of the treatment outweighed the risks.
For the uninitiated, DKA is a life-threatening condition in which ketones build up when the body starts to utilize fat instead of glucose as a source of energy. Patients who were treated with the drug stated that it decreased blood sugar fluctuations and helped them lose weight.
Martha Nason, FDA Panel Member, who voted against the approval, was reportedly quoted stating that she was not convinced Sotagliflozin was a reasonable trade-off. Rachele Berria, Head of U.S. Diabetes Medical Unit, Sanofi, on the other hand, claimed that the drug is for patients who are committed in their self-care and willing to follow monitoring procedures.
By March 22, the federal agency is expected to make a final decision.