FDA
18th November 2019

Panel Does Not Recommend Expanding the Indicated Population for Empagliflozin (Jardiance)

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 13th to discuss the Boehringer Ingelheim Pharmaceuticals.

Panel Does Not Recommend Expanding the Indicated Population for Empagliflozin (Jardiance)

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met on November 13th to discuss the Boehringer Ingelheim Pharmaceuticals, Inc supplemental New Drug Application (sNDA) 204629/S-020 for empagliflozin. The sNDA seeks to expand the  indicated use of empagliflozin, 10-25mg/day, for glycemic control / cardiovascular risk reduction in patients with type-II diabetes to  include type-I diabetes as well as a lower dose of 2.5mg.

Type-II diabetes is a metabolic disease that develops when the body has reduced sensitivity to insulin, a natural hormone that signals for cells to reduce glucose (sugar) circulating in the blood. Type-I diabetes, in contrast is an inherited disorder where insulin sensitivity is lost due to autoimmune factors. When insulin sensitivity is lost the body can no longer regulate blood sugar, leading to toxic levels resulting in a variety of adverse effects,  increased risk of adverse cardiovascular outcomes. The sNDA for this advisory committee includes evidence from the EASE trial which included patients taking insulin injections and compared empagliflozin versus placebo. The study showed a statistically significant reduction in HbA1c, a marker of blood sugar levels over time.

Empagliflozin (brand name Jardiance) is an oral medication that inhibits the sodium-glucose co-transporter-2 (SGLT2) protein. SGLT2 is a protein in the kidneys, the organ that excretes any excessive blood molecules into the bladder. SGLT2 prevents sugar from being excreted unless an excessive blood level is reached. Inhibiting SGLT2 alleviates some of the excess blood sugar found in patients with diabetes. Because blood sugar is an energy source for cells, the body may begin to metabolize fat to make up for the lost energy in response to SGLT2 inhibition. Excessive fat metabolism can lead to a byproduct that can become toxic and cause a condition known as “diabetic ketoacidosis”.

This meeting was comprised of three discussion questions and one voting question. The voting question discussed expanding the indicated population of empagliflozin to include patients with type-I diabetes at a lower dose. The committee voted 2 (YES) to 14 (NO). The panelists who voted “YES” were persuaded by evidence from the EASE trial which demonstrated significant evidence for efficacy. The majority of panelists voted “NO” and expressed concern that the trial was not large enough to demonstrate that the benefits outweighed the risks. The primary concern was that diabetic ketoacidosis had been seen in previous trials with SGLT2 inhibitors at higher doses, and there was not enough evidence to adequately determine if the benefits outweighed the risks in the proposed lower dose.

The agency is not obligated to follow its panels’ recommendation, but normally does so. The sNDA is currently under FDA review.

 

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 info@innovativescience.net

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