AstraZeneca’s drug Farxiga could receive a new indication for a subset of diabetes patients based on Phase III data that was released today.
AstraZeneca Pharmaceuticals LP’s drug Farxiga could receive a new indication for a subset of diabetes patients based on Phase III data that was released today.
The company said Farxiga, an SLG2 inhibitor, hit primary endpoints in Phase III DERIVE study for patients with type 2 diabetes (T2D) with stage 3A chronic kidney disease. The company made the announcement following a presentation of the data at the Endocrine Society’s 100th Annual Meeting and Expo. The 321 patient DERIVE trial hit its primary and secondary endpoints. AstraZeneca said Farxiga (dapagliflozin 10 mg) decreased mean hemoglobin A1C (HbA1C) by .37 percent at week 24. That was in comparison to placebo, which reduced HbA1C by .03 percent during the same time period, a difference of .34 percent.
In addition to the reduction of hemoglobin A1C AstraZeneca researchers also tracked body weight, fasting plasma glucose and systolic blood pressure during the trial. Patients who took Farxiga saw a significant reduction in body weight of 3.17 kg, or about 7 pounds, during the 24 week period. That was in comparison to a 1.92 kg reduction for placebo patients, or 4.2 pounds, a difference of 1.25 kg, about 2.75 pounds.
Patients on Farxiga also saw a significantly important 21.46 mg reduction in mean fasting plasma glucose. Placebo patients recorded a 4.87 mg cut during the 24-week time frame. In systolic blood pressure, the Farxiga group saw a 4.8 mm Hg reduction compared to 1.7 mm Hg in the placebo group. That was a difference of 3.1 mm HG.
“We are committed to helping patients with complex and comorbid diseases like T2D and chronic kidney disease, which is demonstrated through the breadth of our research and our unique cardiovascular, renal and metabolic approach. The DERIVE study will help us learn more and provide additional data for Farxiga in T2D,” Jim McDermott, head of U.S. medical affairs for diabetes at AstraZeneca said in a statement.
SLG2 inhibitors, such as Farxiga, Merck’s recently approved Steglatro, Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance, allow diabetes patients to excrete excess glucose through their urine.
AstraZeneca said the DERIVE trial adds important information to previous studies of Farxiga in type 2 diabetes and moderate renal impairment. Based on the results of this trial AstraZeneca said it will submit the data to the FDA to “add to the breadth of data already contained within the existing Farxiga Prescribing Information.”
There are an estimated 30.3 million people in the United States with diabetes, according to the U.S. Centers for Disease Control and Prevention. Of those people, between 90 and 95 percent have type 2 diabetes, which is the leading cause of chronic kidney disease in the U.S.
The company said adverse events related to the study treatment occurred in about 10.6 percent of patients on Farxiga and in 6.2 percent of placebo patients. The most commonly reported adverse events were urinary tract infection and pollakiuria, frequent urination.
