Empagliflozin Application for Pediatric Type 2 Diabetes Gets FDA Review

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for empagliflozin as an adjunct to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes mellitus (T2DM).

The sNDA is supported by data from the phase 3 DINAMO trial (ClinicalTrials.gov Identifier: NCT03429543), which evaluated the efficacy and safety of empagliflozin as an adjunct to diet and exercise in patients 10 to less than 18 years of age with T2DM who were currently receiving metformin, insulin, or both. Patients were randomly assigned 1:1:1 to receive empagliflozin 10mg, linagliptin 5mg, or placebo orally once daily. At week 12, empagliflozin-treated patients who did not achieve an HbA1c of less than 7% were re-randomized to remain on 10mg or increase to 25mg.

Results showed that empagliflozin (pooled 10mg and 25mg doses) in addition to other baseline therapies (diet, exercise, metformin and/or insulin) reduced HbA1c by 0.84% at week 26 compared with placebo (95% CI, -1.50, -0.19; P =.012). Treatment with linagliptin did not achieve statistical significance in HbA1c reduction when compared with placebo. The overall safety profile of empagliflozin was generally consistent with previous findings in adults with T2DM.

“There are clear unmet needs for young people living with type 2 diabetes, which has nearly doubled in prevalence in people aged 10-19 over the past 2 decades,” said Mohamed Eid, MD, MPH, MHA, vice president, Clinical Development & Medical Affairs, Cardio-Renal-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. “We look forward to working closely with the FDA during the review process and while we await a decision on our efforts to bring another potential treatment option to children 10 years and older with type 2 diabetes.”

Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently marketed under the brand name Jardiance as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. It is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with HF; and to reduce the risk of cardiovascular (CV) death in adults with T2DM and established CV disease.

Want to read more?