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Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault