FDA accepts new drug application for empagliflozin, metformin combo therapy

The FDA accepted the filing of a new drug application for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination to treat adults with type 2 diabetes, according to a release from Boehringer Ingelheim and Eli Lilly and Company.

“The FDA’s acceptance of the new drug application … brings us one step closer to offering a potential new treatment option that may help patients better manage their type 2 diabetes through one pill that combines two distinct approaches to help control blood sugar,” Christophe Arbet-Engels, MD, PhD, vice president of metabolic-clinical development and medical affairs at Boehringer Ingelheim Pharmaceuticals, said in the statement.

Included in the filing are data from multiple clinical trials investigating empagliflozin (Jardiance, Boehringer Ingelheim) — approved by the FDA in August as an adjunct to diet and exercise to improve glycemic control — and metformin to treat 4,740 adults with type 2 diabetes, according to the release.

Empagliflozin is not recommended for people with type 1 diabetes or for the treatment of diabetic ketoacidosis, according to the statement

Potential adverse effects seen with treatment include dehydration that may cause patients to feel dizzy, faint, light-headed or weak, vaginal yeast infection and yeast infection of the penis; the most common adverse events are urinary tract infections and yeast infections in females, according to the release. Hypoglycemia also is a potential adverse effect when paired with sulfonylurea or insulin.