Proposal to Have Empagliflozin as Option for Children with Type 2 Diabetes

Cases of type 2 diabetes among children aged 10 and above have been on the rise for the last 20 years with manufacturers of Jardiance, which contains the drug empagliflozin, which is used in the treatment of diabetes in adults, seeking approval in the US to make a version of the medicine to meet increasing demand from this group of young diabetes patients.

Although a rare disease for children and youth, type 2 diabetes among this group has been characterized by aggressiveness, rapid decline of beta cells, high treatment failure and quick development of associated complications according to a previous study. (1)

Currently, management of the disease among children has largely revolved around diet improvement, exercise, and use of drugs such as metformin that helps the insulin that type 2 diabetes patients produce function well.

In early March 2023 Boehringer Ingelheim and Eli Lilly and Company, which manufacture Jardiance, announced the acceptance by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application (sNDA) for empagliflozin “investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes.” (2)

The two companies, which launched a partnership in 2011 to jointly develop and commercialize a portfolio of diabetes compounds currently in mid- and late-stage development at the time, say despite the number of people living with type 2 diabetes going up by 100% in the last 20 years, demand for appropriate drugs options remains unmet.

FDA is in the process of reviewing the sNDA with Boehringer Ingelheim committing itself to work with the US drugs Agency in the interim period “while we await a decision on our efforts to bring another potential treatment option to children 10 years and older with type 2 diabetes."

Optimism is high after recent trials showed Jardiance film coated 10 mg and 25 mg tablet to have positive recovery impact among participants aged 10 to 17 years who have type 2 diabetes.

The empagliflozin drug in Jardiance is one of the three approved sodium-glucose co-transporter 2 (SGLT 2) inhibitors for type 2 diabetes that help lower blood sugar by causing the kidneys to remove sugar from the body through urine. Other inhibitors in this category include canagliflozin and dapagliflozin.

Jardiance, which was approved 8 years ago, is a once-daily tablet used alongside eating a good diet and exercise to lower blood sugar in adults with type 2 diabetes according to Boehringer Ingelheim.

The 10 mg Jardiance tablet is round, pale yellow, biconvex, bevel-edged film-coated tablet while the 25 mg oval, pale yellow, biconvex film-coated tablet.

The drug also reduces “the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease.”

The application by Boehringer Ingelheim and Eli Lilly and Company, if approved by the FDA, would make Jardiance a new oral treatment alternative for children 10 years and older with type 2 diabetes in the US.

Previously, FDA had cautioned use of SGLT 2 inhibitors could lead to necrotizing fasciitis of the perineum, a rare infection of the genitals and the area around the genitals.

The complication comes with symptoms such as tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum as well as high fever.

FDA says the symptoms have been seen to rapidly worsen requiring patients to urgently seek treatment.

References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040084/

2. https://investor.lilly.com/news-releases/news-release-details/us-fda-accepts-supplemental-new-drug-application-jardiancer-1

3. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2-inhibitors-diabetes

About the Author

Shem Oirere graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy, and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.