Eli Lilly, Boehringer Ingelheim get approval to expand Jardiance, Synjardy labels to kids with type 2 diabetes

Eli Lilly and Boehringer Ingelheim won FDA approval to expand empagliflozin’s label to include adolescents with type 2 diabetes.

The SGLT2 inhibitor, better known as Jardiance, was first approved to improve glycemic control in adults with type 2 diabetes in 2014. On Tuesday, the drug under the brand name Jardiance received an expanded label to lower blood sugar in 10- to 17-year-old patients with type 2 diabetes in conjunction with diet and exercise. It’s also now approved in combination with metformin, the only other oral therapy available for children with type 2 diabetes, for the 10 to 17 age group, for which it will be marketed as Synjardy.

“This will be the first SGLT2 inhibitor to be indicated in that age category,” Mohamed Eid, Boehringer’s VP of clinical development and medical affairs in the cardio-renal-metabolism and respiratory medicine business, said in an interview prior to the Jardiance approval. “We have very, very strong data to show that it’s really important to intervene early and effectively to manage blood sugar in people with type 2 diabetes.”

Mohamed Eid

The FDA granted the expansion based on data from the Phase III DINAMO trial, which showed pooled 10 mg and 25 mg empagliflozin dose levels lowered A1c levels in kids between the ages of 10 and 17 years old by a statistically significant 0.84% compared to placebo at 26 weeks. Patients had A1c levels ranging from 6.5% to 10.5% at baseline, according to Eid.

“I can tell you from my own endocrine practice days that’s actually quite a substantial number,” Eid said when asked about the treatment effect. He noted two considerations: Glucose control is difficult to manage in the 10- to 17-year-old population, and patients were also treated with standard of care, including metformin and/or insulin.

“That increment that you see is actually beyond what they have been able to accomplish with that background therapy,” he said.

Empagliflozin’s safety profile in adolescents was consistent with what researchers have previously seen in adult patients taking the drug. However, the FDA noted in a news release on Tuesday that children 10 years and older had a higher risk of low blood sugar compared to placebo, regardless of whether they were taking other therapies for diabetes.

Research had showed an uptick in childhood diabetes, with the rate of kids with type 2 diabetes nearly doubling from 2001 to 2017, according to a JAMA study in 2021. If the trend continues, type 2 diabetes incidence in youth could skyrocket more than 670% from 2017 to 2060, according to research published in Diabetes Care in 2022.

“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” Michelle Carey, associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a news release.

Jardiance, which includes Glyxambi, Synjardy, and Trijardy, generated $2.2 billion in sales last year, according to Lilly’s annual report. It’s received a suite of heart-related indications that put it in competition with AstraZeneca’s Farxiga and J&J’s Invokana, both of which are also SGLT2 inhibitors, which work by targeting a protein in the kidneys that affects how the body reabsorbs glucose. By blocking the SGLT2 protein, they lower reabsorption and thus blood sugar levels. TheracosBio’s Brenzavvy is the newest entrant to the market after the therapy received FDA approval earlier this year for an indication for type 2 diabetes patients in addition to diet and exercise.

Boehringer Ingelheim also tested Tradjenta, or linagliptin, in the same setting in adolescents, but the drug failed to achieve a statistically significant reduction. Empagliflozin and linagliptin are currently approved in combination to treat adults with type 2 diabetes, where the combo is marketed as Glyxambi. Synjardy, meanwhile, was first approved in 2015 as a combination of empagliflozin and metformin to help control blood glucose in adults with type 2 diabetes.

The FDA is expected to decide later this year whether to approve Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.

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