AstraZeneca and Bristol-Myers Squibb Company have announced the U.S. Food and Drug Administration (FDA) approval of Farxiga in a press release featured in the Wall Street Journal.
Farxiga (Forxiga® outside the US) is a new, once-daily oral drug used to improve glycemic control in Type 2 diabetic adults (together with proper diet and exercise). The recommended dose for Farxiga starts at 5 mg once daily, preferably taken in the morning with or without food. Farxiga is not recommended for treatment of type 1 diabetes and diabetic ketoacidosis.
Bristol-Myers Squibb global developmental and medical affairs Vice President Brian Daniels hailed Farxiga as an important, novel option both for patients and healthcare professionals. “In clinical trials, FARXIGA helped improve glycemic control, and offered additional benefits of weight and blood pressure reductions,” he said in the Bristol-Myers Squibb press release.
Farxiga’s clinical development program constituted of 24 clinical studies on safety and efficacy. 11,000 adults with type 2 diabetes were treated with the drug including over 6,000 patients. Farxiga is a sodium-glucose cotransporter 2 (SGLT2) inhibitor which works by removing glucose through the kidneys. The drug is contraindicated in patients with severe renal impairment, end stage renal disease, or those on dialysis. Patients with a history of serious, hypersensitive reaction to the drug are also contraindicated.
AstraZeneca’s Global Medicines Development chief medical officer and executive vice president Briggs Morrison, M.D., said, “The addition of FARXIGA to our U.S. treatment portfolio is a step forward as we work to help reduce the burden of type 2 diabetes by offering a range of treatment options with different modes of action… We aim to help adults with type 2 diabetes, and their doctors, create individualized treatment programs that will help patients lower their glucose levels.”
Farxiga (dapagliflozin) is approved for type 2 adult diabetes treatment, in addition to exercise and diet, in 40 countries including Australia and European Union nations.