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U.S. FDA Approves Farxiga™ (Dapagliflozin) Tablets For The Treatment Of Adult Patients With Type 2 Diabetes

AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb Company (NYSE:BMY) announced the U.S. Food and Drug Administration (FDA) approved Farxiga™ [far-SEE-ga] (dapagliflozin), a once-daily oral treatment indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Farxiga should not be used for the treatment of patients with type 1 diabetes or diabetic ketoacidosis.

The recommended starting dose of Farxiga is 5 mg once daily, taken in the morning, with or without food. In patients tolerating Farxiga 5 mg once daily who require additional glycemic control, the dose can be increased to 10 mg once daily. Farxiga is part of a newer class of medicines called sodium-glucose cotransporter 2 (SGLT2) inhibitors, which remove glucose via the kidneys.

“With the diabetes epidemic escalating and many people with type 2 diabetes struggling to reach their blood sugar goals, Farxiga offers an important new option for healthcare professionals and adult patients,” said Brian Daniels, senior vice president, global development and medical affairs, Bristol-Myers Squibb. “In clinical trials, Farxiga helped improve glycemic control, and offered additional benefits of weight and blood pressure reductions.”

Farxiga is contraindicated in patients with a history of a serious hypersensitivity reaction to Farxiga or with severe renal impairment, end stage renal disease, or patients on dialysis.

“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,” said Briggs Morrison, M.D., executive vice president, Global Medicines Development and chief medical officer, AstraZeneca. “We aim to help adults with type 2 diabetes, and their doctors, create individualized treatment programs that will help patients lower their glucose levels.”

Dapagliflozin (marketed outside of the United States as Forxiga ®) is approved for the treatment of adults with type 2 diabetes, along with diet and exercise, in 40 countries, including European Union countries and Australia.

Farxiga Clinical Development Program

The robust Farxiga clinical development program included 24 clinical studies evaluating safety and efficacy. The studies included more than 11,000 adults with type 2 diabetes, including more than 6,000 patients treated with Farxiga.

Farxiga causes intravascular volume contraction. Symptomatic hypotension can occur after initiating Farxiga particularly in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m 2), elderly patients, or patients on loop diuretics. Before initiating Farxiga in patients with one or more of these characteristics, volume status should be assessed and corrected. Monitor for signs and symptoms of hypotension after initiating therapy. Farxiga increases serum creatinine and decreases eGFR. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Adverse reactions related to renal function can occur after initiating Farxiga. Renal function should be evaluated prior to initiation of Farxiga and monitored periodically thereafter.

In a 24-week, add-on to metformin clinical trial, adult patients with type 2 diabetes treated with Farxiga 5 mg (n=137; baseline HbA1c 8.2%) or 10 mg (n=135; baseline A1c 7.9%) had significant reductions in HbA1c of -0.7% and -0.8%, respectively, compared with placebo plus metformin reductions of -0.3% (n=137; baseline HbA1c 8.1%). In the same study, the placebo-adjusted reduction in body weight was -2.2 kg with Farxiga 5 mg (baseline 84.7 kg) and -2.0 kg with 10 mg (baseline 86.3 kg). Also, mean changes from baseline in systolic blood pressure relative to placebo plus metformin were -4.5 mmHg and -5.3 mmHg with Farxiga 5 mg or 10 mg plus metformin, respectively. No major episodes of hypoglycemia were seen in any of the treatment arms. Minor episodes of hypoglycemia were reported in 1.5%, 0.7%, and 0% with Farxiga 5 mg, 10 mg, and placebo plus metformin, respectively.

In addition to the clinical development program, the AstraZeneca/Bristol-Myers Squibb Diabetes Alliance has initiated DECLARE, a large, randomized, placebo-controlled study of more than 17,000 adult patients with type 2 diabetes designed to determine the effect of Farxiga, when added to the patients’ current anti-diabetes therapy, on the risk of CV events, such as CV death, myocardial infarction or ischemic stroke, compared with placebo. The study, which will also provide additional data on the long-term safety profile, initiated enrollment in April 2013 and has an anticipated completion date of 2019.

INDICATION AND LIMITATION OF USE FOR FARXIGA™ (dapagliflozin)

Farxiga is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Farxiga is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION FOR FARXIGA

Contraindications

• History of a serious hypersensitivity reaction to Farxiga

• Severe renal impairment, end stage renal disease, or patients on dialysis

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