Ruud Dobber, executive VP of biopharmaceuticals at AstraZeneca was quoted in a press release dated saying that type 2 diabetes is on the rise in adolescents and younger children with no corresponding rise in treatment options. Metformin, at the time of its approval in 2000, was the only other oral therapy approved for pediatric use.
Addressing this need, he further stated that the FDA approved the SGLT2 inhibitor dapagliflozin on June 12th of this year to treat glycemic control for children 10 years of age and older who have type 2 diabetes.
The drug had initially been FDA approved in 2013 to treat adults with type 2 diabetes to be used as an adjunct to their exercise and diet plans as well as a method of glycemic control. The recent FDA approval was based on the positive results of the Phase III T2NOW trial comparing saxagliptin or dapagliflozin in T2D. The trial was one of the largest pediatric Phase III clinical trials conducted to date.
The adolescents and children with T2D who participated in the trial and who were receiving insulin, metformin, or both, for purposes of the trial were assigned 5 mg or 10 mg dapagliflozin (Farxiga®), 2.5 mg or 5 mg saxagliptin, or placebo as an add on treatment for twenty-six weeks.
About Type 2 Diabetes (T2D)
Type 2 affects people of any age. The disorder occurs when the body is unable to regulate and use sugar as fuel. There are approximately 30,000 people under 20 years of age currently diagnosed with T2D in the U.S. with 5,500 new cases reported annually by the CDC. Younger patients usually experience earlier symptoms and more rapid progression than adults who have the disorder.
At week 26, the trial data showed that A1C was substantially reduced. A1C acts as a marker to gauge the average blood sugar for Farxiga® patients compared to those patients who received placebo. The safety results were in line with previously reported results for Farxiga®.
The SGLT2 inhibitor has been approved in 126 countries, including the EU, and marketed under the brand name Farxiga. Farxiga® has also received approval to treat heart failure and adults diagnosed with kidney disease.
