Market Expansion: Dapagliflozin Receives FDA Approval for Treating Type 2 Diabetes in Children

Views: 19     Author: Unibest Industrial     Publish Time: 2024-06-13      Origin: Site

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AstraZeneca has announced on June 12, 2024, that Farxiga (dapagliflozin) has been approved by the U.S. Food and Drug Administration (FDA) for improving glycemic control in children aged 10 years and above with type 2 diabetes (T2D). The FDA approval is based on the positive results from the Phase 3 pediatric clinical trial, T2NOW. Farxiga was previously approved in the U.S. for treating adult patients with T2D as an adjunct to diet and exercise to improve glycemic control.


Data from the Phase 3 T2NOW trial showed that patients receiving Farxiga treatment had a significantly greater reduction in glycated hemoglobin (A1C) compared to the placebo group. The mean change in A1C was -0.62 percentage points for the Farxiga group, while the placebo group showed an increase of +0.41 percentage points, resulting in a difference of -1.03 percentage points (95% CI: -1.57, 0.49; p<0.001). At week 26, the primary endpoint and all secondary endpoints were met with statistical significance compared to placebo, demonstrating that Farxiga provides clinically meaningful improvements in glycemic control for children and adolescents with T2D. The safety profile in this patient population was consistent with that observed in adult T2D patients and aligned with the known safety profile of Farxiga.


Type 2 diabetes is a chronic disease affecting people of all ages. Globally, the incidence of T2D in children and adolescents is increasing. According to the Centers for Disease Control and Prevention and recent studies, in the U.S. alone, there are nearly 30,000 patients under the age of 20 with T2D, with 5,300 new cases annually. Compared to adults with the same condition, younger patients often experience complications earlier and have a more rapid disease progression.

About Dapagliflozin

Dapagliflozin is a first-in-class sodium-glucose cotransporter 2 (SGLT2) inhibitor, first approved in 2008. As of June 2024, it has been approved in 126 countries and regions as an adjunct to diet and exercise to improve glycemic control in adult patients with T2D. Additionally, it has been approved in over 100 countries and regions worldwide for the treatment of adult patients with heart failure (including heart failure with reduced ejection fraction and heart failure with preserved ejection fraction) and chronic kidney disease (CKD).

Structure of Dapagliflozin, CAS No. 461432-26-8

Structure of Dapagliflozin, CAS No. 461432-26-8; first approved by FDA in 2008

About SGLT2 inhibitors

Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are a groundbreaking class of antidiabetic medication that have revolutionized the treatment of diabetes. These drugs work by inhibiting the absorption of glucose from the proximal tubule of the kidney, leading to increased glucose excretion in the urine (glycosuria). This unique mechanism of action sets SGLT2i apart from other antidiabetic medications.

One of the most notable benefits of SGLT2i is their ability to reduce glycated hemoglobin (HbA1c) levels by 0.5% to 1.0%. This significant reduction in HbA1c can help patients achieve better glycemic control and reduce the risk of diabetes-related complications. Additionally, SGLT2i have shown favorable effects on various other health parameters, including body weight, blood pressure, lipid profile, arterial stiffness, and endothelial function.

Perhaps the most exciting aspect of SGLT2i is their impressive cardioprotective and renoprotective effects. These drugs have been shown to reduce the risk of cardiovascular events, such as heart attacks and strokes, as well as slow the progression of kidney disease in patients with diabetes. The mechanisms behind these protective effects are multifaceted and include improvement in cardiac cell metabolism, optimization of ventricular loading conditions, inhibition of the Na+/H+ exchange in myocardial cells, alteration in adipokine and cytokine production, and reduction of cardiac cell necrosis and fibrosis.

While SGLT2i offer numerous benefits, it is important to be aware of potential adverse events associated with their use. The most common side effects include urinary tract and genital infections, which can be managed with proper hygiene and prompt treatment. In rare cases, SGLT2i may also cause euglycemic diabetic ketoacidosis, a serious condition that requires immediate medical attention.

Despite these potential drawbacks, the benefits of SGLT2i far outweigh the risks for most patients with diabetes. As research continues to uncover new applications and long-term effects of these drugs, it is clear that SGLT2i will play an increasingly important role in the management of diabetes and its complications. At the time of writing, there have been together of 6 SGLT2i drugs approved by the FDA.

Structure of Canaglifozion, CAS No. 842133-18-0

Structure of Canaglifozion, CAS No. 842133-18-0; first approved by FDA in 2013 (A-S Medication Solutions; Janssen Pharmaceuticals, Inc.; Cardinal Health 107, LLC)

Structure of Empagliflozin, CAS No. 864070-44-0

Structure of Empagliflozin, CAS No. 864070-44-0; first approved by FDA in 2014 (A-S Medication Solutions; Boehringer Ingelheim Pharmaceuticals, Inc.; Aphena Pharma Solutions - Tennessee, LLC; Cardinal Health 107, LLC)

Structure of Ertugliflozin, CAS No. 1210344-57-2

Structure of Ertugliflozin, CAS No. 1210344-57-2; first approved by FDA in 2017 (A-S Medication Solutions; Merck Sharp & Dohme Llc)

Structure of Sotagliflozin, CAS No. 1018899-04-1

Structure of Sotagliflozin, CAS No. 1018899-04-1; first approved by FDA in 2023 (Lexicon Pharmaceuticals, Inc.)

Structure of Bexagliflozin, CAS No. 1118567-05-7

Structure of Bexagliflozin, CAS No. 1118567-05-7; first approved by FDA in 2023 (TheracosBio, LLC; Golden State Medical Supply, Inc.)


Tentolouris, A., Vlachakis, P., Tzeravini, E., Eleftheriadou, I. & Tentolouris, N. SGLT2 Inhibitors: A Review of Their Antidiabetic and Cardioprotective Effects. IJERPH 16, 2965 (2019).
Verma, S. & McMurray, J. J. V. SGLT2 inhibitors and mechanisms of cardiovascular benefit: a state-of-the-art review. Diabetologia 61, 2108–2117 (2018).
AstraZeneca. Farxiga approved in the US for the treatment of paediatric type-2 diabetes. (2024).