AstraZeneca said that it has received an expanded indication approval for Forxiga, its sodium-glucose cotransporter-2 (SGLT-2) inhibitor for type 2 diabetes patients, from the Ministry of Food and Drug Safety.
|AstraZeneca's SGLT-2 inhibitor Forxiga|
Under the new approval, the range of license for the drug has been extended for use in patients with type 2 diabetes with moderate renal failure who have an estimated glomerular filtration rate (eGFR) of 45 ml/min/1.73m2 or more.
The expanded indication means that hospitals will now be able to use Forxiga even if the patient who started treatment at an eGFR 60ml/min/1.73m2 or higher see the figures drop to eGFR 45 ml/min/1.73m2.
The ministry approved the expanded indication after AstraZeneca confirmed the treatment's efficacy through a phase 3 DERIVE study. After conducting a placebo-controlled study with type 2 diabetes patients with poor glycemic control and an eGFR of 45-59 mL/min/1.73m2, the company confirmed that Forxiga significantly decreased glycated hemoglobin, body weight, fasting glucose and systolic blood pressure at week 24.
The safety profile was also similar to that of previous clinical studies.
Diabetic nephropathy is a major complication experienced by 20 to 40 percent of diabetic patients. As it continues to impair kidney function, hospitals recommend early detection and active treatment strategies to prevent progression to end-stage renal failure, which requires dialysis or kidney transplantation.
Therefore, there is a high need for active management through drug administration from the onset of the disease to prevent diabetes complications.
"The expansion is expected to provide treatment options for more people with type 2 diabetes who need to manage renal complications," said Chon Se-whan, director of AstraZeneca's cardiovascular, renal & metabolism (CVRM) business unit. "As Forxiga is one of the leading SGLT-2 inhibitor drugs, AstraZeneca will work harder to treat patients with type 2 diabetes better."