On January 17th, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed.
On January 17th, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) reviewed the New Drug Application (NDA) 210934 sotagliflozin (Sanofi-Aventis U.S., LLC.) which seeks approval of sotagliflozin as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
Sotagliflozin is a dual inhibitor of sodium-glucose cotransporter 1 (SGLT1) and sodium-glucose cotransporter 2 (SGLT2). It lowers plasma glucose by increasing urinary glucose excretion and purports to alter improved glycemic control by lowering hemoglobin A1c (HbA1c), reduced hypoglycemia and reduced body weight based on results of three phase 3 clinical trials.
In this meeting, there were 4 discussion questions and 1 voting question. The main voting question on whether benefits outweigh the risk and support for approval resulted in a tie (8 YES to 8 NO).
The committee members in support of the product noted that the drug can be beneficial if the patient understands the risks and follows strict monitoring methods. Most felt that the applicant’s post meeting plan could further define risks in the larger population. Those who voted no, expressed that the company failed to show data supporting ketone monitoring and risk mitigation strategies. They emphasized their concern about the observed risk of diabetic ketoacidosis (DKA) in the phase 3 studies. Specifically, they worry that DKA risk will be higher in the real world.
The agency is not obligated to follow its panel’s recommendation, but normally does so.
On March 22nd, the FDA issued a Complete Response Letter (CRL). The letter informed Sanofi-Aventis that the current application cannot be approved in its present form. As of now, the company is currently working with the FDA to determine the next appropriate steps.
ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org
This blog post was authored by Sharon Christian. Sharon is a summer intern at ISS and an undergraduate student at Rutgers University.
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