FDA approves Empagliflozin tablets for patients with type 2 diabetes

Empagliflozin tablets were today approved by the FDA to help patients with type 2 diabetes improve glucose control, according to a press release.

The sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance, Lilly) can be used as a stand-alone therapy or combined with other treatment regimens, according to the release.

“Many adults with type 2 diabetes still have difficulty controlling their blood sugar levels even with treatment. There is a critical need for new treatment options to help these patients,” Christophe Arbet-Engels, MD, PhD, vice president of metabolic-clinical development and medical affairs at Boehringer Ingelheim Pharmaceuticals, Inc., said in a statement. “This approval by the FDA is an exciting development for both adults with type 2 diabetes and the physicians who care for them.”

Empagliflozin blocks the reabsorption of glucose by the kidney, thereby increasing glucose excretion and lowering blood glucose levels in people with type 2 diabetes with elevated blood glucose levels.

Seven trials involving 4,480 patients demonstrated safety and efficacy of empagliflozin, both alone or combined with metformin, sulfonylureas, pioglitazone and insulin. Pivotal trials showed improvements in HbA1c levels when compared with placebo.

The therapy should not be used for patients with type 1 diabetes, increased ketones in their blood or urine, severe renal impairment, end stage renal disease or for patients undergoing dialysis, the press release said.

Four post-marketing studies have been required by the FDA for cardiovascular outcomes, pediatric pharmacokinetics/pharmacodynamics, pediatric safety and efficacy including bone health and development measures and toxicity (non-clinical animal) focused on growth and renal and bone development.

Common side effects of empagliflozin include urinary tract infections and female genital infections. The therapy could cause dehydration, along with hypotension that may result in dizziness, fainting and renal function decline; older patients, and those with impaired renal function or on diuretics are more susceptible to this risk.

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