WILMINGTON, Del., Oct 30, 2014 (BUSINESS WIRE) --AstraZeneca
AZN, +0.14%
today announced that the U.S. Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.
XIGDUO XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the U.S. FARXIGA™), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.
XIGDUO XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. XIGDUO XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
XIGDUO XR is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. The product label for XIGDUO XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with XIGDUO XR.
XIGDUO XR is contraindicated in patients with moderate to severe renal impairment; a history of a serious hypersensitivity to dapagliflozin or to metformin HCl; or with metabolic acidosis, including diabetic ketoacidosis.
“The addition of XIGDUO XR to our U.S. diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca. “The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”
XIGDUO XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. XIGDUO (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.
XIGDUO XR Dosing
XIGDUO XR is approved with multiple dosage strengths of dapagliflozin and metformin HCl extended-release, respectively, including 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, and the starting dose should be individualized based on each patient’s current treatment regimen. XIGDUO XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk of gastrointestinal (GI) side effects due to metformin. The maximum daily recommended dose is 10 mg for dapagliflozin and 2,000 mg for metformin HCl. Dapagliflozin causes intravascular volume contraction. Symptomatic hypotension can occur after initiating dapagliflozin, particularly in patients with impaired renal function (eGFR
AZN, +0.14%
today announced that the U.S. Food and Drug Administration has approved once-daily XIGDUO™ XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes.
XIGDUO XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the U.S. FARXIGA™), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride (HCl) extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.
XIGDUO XR is the first and only once-daily combination tablet of an SGLT2 inhibitor and metformin HCl extended-release to be approved in the United States. XIGDUO XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
XIGDUO XR is not recommended for patients with type 1 diabetes or diabetic ketoacidosis. The product label for XIGDUO XR contains a boxed warning for lactic acidosis, a rare, but serious metabolic complication that can occur due to metformin accumulation during treatment with XIGDUO XR.
XIGDUO XR is contraindicated in patients with moderate to severe renal impairment; a history of a serious hypersensitivity to dapagliflozin or to metformin HCl; or with metabolic acidosis, including diabetic ketoacidosis.
“The addition of XIGDUO XR to our U.S. diabetes portfolio is further evidence of AstraZeneca’s commitment to develop new treatment options for patients with type 2 diabetes,” said Elisabeth Björk, Head of Cardiovascular & Metabolism, Global Medicines Development, AstraZeneca. “The approval of once-daily XIGDUO XR provides prescribers and adult patients with another treatment choice, supporting a more personalized approach to disease management.”
XIGDUO XR is already approved in Australia for the treatment of adults with type 2 diabetes, along with diet and exercise. XIGDUO (dapagliflozin and metformin hydrochloride), which uses an immediate-release form of metformin, is approved in the European Union.
XIGDUO XR Dosing
XIGDUO XR is approved with multiple dosage strengths of dapagliflozin and metformin HCl extended-release, respectively, including 5 mg/500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, and the starting dose should be individualized based on each patient’s current treatment regimen. XIGDUO XR should be taken once daily in the morning with food with gradual dose escalation to reduce the risk of gastrointestinal (GI) side effects due to metformin. The maximum daily recommended dose is 10 mg for dapagliflozin and 2,000 mg for metformin HCl. Dapagliflozin causes intravascular volume contraction. Symptomatic hypotension can occur after initiating dapagliflozin, particularly in patients with impaired renal function (eGFR
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