Sanofi and Lexicon Pharmaceuticals have received split decision from an advisory panel to the US Food and Drug Administration (FDA) on whether to recommend diabetes drug Zynquista (sotagliflozin) for approval.
Jointly developed by the companies, sotagliflozin is an investigational, oral dual SGLT1 and SGLT2 inhibitor being reviewed as an adjunct therapy to insulin for adults living with type 1 diabetes.
The committee was split eight to eight when voting if the overall benefits of the drug outweighed the associated risks.
Sanofi Diabetes Medical Affairs global vice-president and head Rachele Berria said: “We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 diabetes who lack adequate glycemic control using insulin alone.
“We will continue to work with the FDA through its review process to hopefully bring to patients a new treatment that can help people living with type 1 diabetes control their blood sugar and address some of the challenges of insulin-only therapy.”
The new drug application submitted to the regulatory agency included results from the inTandem clinical trial programme of sotagliflozin.
Under the programme, three Phase III clinical trials were conducted to evaluate the safety and efficacy of the drug in nearly 3,000 adults with inadequately controlled type-1 diabetes.
According to Reuters, trial participants who attended the panel meeting were in favour of the drug’s effectiveness, but FDA staff identified the risk of diabetic ketoacidosis (DKA).
The news agency added that Sanofi and Lexicon proposed a risk evaluation and mitigation strategy (REMS) to educate patients and physicians. Besides, patients using the drug will be required to undergo regular ketone level testing.
Panel member Rebecca Brown was quoted by Reuters as saying: “The task going forward will be to have a REMS strategy that will effectively select and maintain the patients and providers who can use this drug in the safest way possible.”
The FDA is not obligated to adhere to the committee’s vote, but it does take note of the panel’s recommendations. The regulatory agency is scheduled to make its decision on sotagliflozin by 22 March this year.