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The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.
Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."
The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.
Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.
There is also a boxed warning on the potential for lactic acidosis.
On Twitter @aliciaault
The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.
Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."
The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.
Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.
There is also a boxed warning on the potential for lactic acidosis.
On Twitter @aliciaault
The Food and Drug Administration has approved Invokamet, a fixed-dose combination of canagliflozin, a sodium-glucose cotransporter 2 inhibitor, and metformin, for type 2 diabetes.
Janssen Pharmaceuticals, which will market Invokamet in the United States, says that it’s the first such combination approved by the FDA. Specifically, the indication is "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications."
The drug will be available in four dosage combinations containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dose is twice daily.
Canagliflozin was originally approved by the FDA in March 2013. During three phase III trials of canagliflozin plus metformin, the combination "lowered blood sugar and, in pre-specified secondary endpoints, was associated with significant reductions in body weight and systolic blood pressure," according to the statement. The most common adverse events were female genital mycotic infections, urinary tract infections, and increased urination. The most common adverse reactions with metformin were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. Canagliflozin can increase the risk of hypoglycemia when combined with insulin or a sulfonylurea. The company says that lower doses of those therapies may be required to minimize the risk of hypoglycemia when used in combination with Invokamet.
There is also a boxed warning on the potential for lactic acidosis.
On Twitter @aliciaault
