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The Food and Drug Administration has approved once-daily oral empagliflozin for adults with type 2 diabetes, based on seven studies with nearly 4,500 patients.
Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. It has been studied "as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylureas, pioglitazone, and insulin," according to an Aug. 1 FDA statement announcing the approval.
Boehringer Ingelheim Pharmaceuticals will market empagliflozin as Jardiance.
This is the third SGLT2 inhibitor approved by the FDA, following the approval of dapagliflozin (Farxiga) in January 2014 and canagliflozin (Invokana) in March 2013.
The most common side effects of treatment are genital infections in women and urinary tract infections, according to the FDA. Treatment can also cause dehydration resulting in hypotension, with dizziness and/or fainting, as well as reduced renal function. "The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk," the FDA noted.
Empagliflozin should not be used to treat patients with severe renal impairment or end-stage renal disease, or who are on dialysis. The drug also should not be used in patients with diabetic ketoacidosis and those with type 1 diabetes.
Boehringer Ingelheim must conduct four postmarketing studies of empagliflozin: a cardiovascular outcomes trial, which is already underway; a pediatric pharmacokinetic/pharmacodynamic study; a pediatric safety and efficacy study (which will include evaluations of bone health and development); and a juvenile animal toxicity study. The animal study will have "a particular focus on renal development, bone development, and growth," the FDA statement said.
In May, the European Commission approved empagliflozin for treating adults with type 2 diabetes.
The Food and Drug Administration has approved once-daily oral empagliflozin for adults with type 2 diabetes, based on seven studies with nearly 4,500 patients.
Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. It has been studied "as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylureas, pioglitazone, and insulin," according to an Aug. 1 FDA statement announcing the approval.
Boehringer Ingelheim Pharmaceuticals will market empagliflozin as Jardiance.
This is the third SGLT2 inhibitor approved by the FDA, following the approval of dapagliflozin (Farxiga) in January 2014 and canagliflozin (Invokana) in March 2013.
The most common side effects of treatment are genital infections in women and urinary tract infections, according to the FDA. Treatment can also cause dehydration resulting in hypotension, with dizziness and/or fainting, as well as reduced renal function. "The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk," the FDA noted.
Empagliflozin should not be used to treat patients with severe renal impairment or end-stage renal disease, or who are on dialysis. The drug also should not be used in patients with diabetic ketoacidosis and those with type 1 diabetes.
Boehringer Ingelheim must conduct four postmarketing studies of empagliflozin: a cardiovascular outcomes trial, which is already underway; a pediatric pharmacokinetic/pharmacodynamic study; a pediatric safety and efficacy study (which will include evaluations of bone health and development); and a juvenile animal toxicity study. The animal study will have "a particular focus on renal development, bone development, and growth," the FDA statement said.
In May, the European Commission approved empagliflozin for treating adults with type 2 diabetes.
The Food and Drug Administration has approved once-daily oral empagliflozin for adults with type 2 diabetes, based on seven studies with nearly 4,500 patients.
Empagliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. It has been studied "as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylureas, pioglitazone, and insulin," according to an Aug. 1 FDA statement announcing the approval.
Boehringer Ingelheim Pharmaceuticals will market empagliflozin as Jardiance.
This is the third SGLT2 inhibitor approved by the FDA, following the approval of dapagliflozin (Farxiga) in January 2014 and canagliflozin (Invokana) in March 2013.
The most common side effects of treatment are genital infections in women and urinary tract infections, according to the FDA. Treatment can also cause dehydration resulting in hypotension, with dizziness and/or fainting, as well as reduced renal function. "The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk," the FDA noted.
Empagliflozin should not be used to treat patients with severe renal impairment or end-stage renal disease, or who are on dialysis. The drug also should not be used in patients with diabetic ketoacidosis and those with type 1 diabetes.
Boehringer Ingelheim must conduct four postmarketing studies of empagliflozin: a cardiovascular outcomes trial, which is already underway; a pediatric pharmacokinetic/pharmacodynamic study; a pediatric safety and efficacy study (which will include evaluations of bone health and development); and a juvenile animal toxicity study. The animal study will have "a particular focus on renal development, bone development, and growth," the FDA statement said.
In May, the European Commission approved empagliflozin for treating adults with type 2 diabetes.
