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Dulaglutide, a glucagon-like peptide-1 receptor agonist administered subcutaneously once a week, has been approved for treatment of adults with type 2 diabetes, the Food and Drug Administration announced Sept. 18.
It was approved with a Risk Evaluation and Mitigation Strategy (REMS) aimed at informing health care professionals about the serious risks of treatment and requirements for postmarketing studies that address some of those risks, the FDA said in a statement.
Approval was based on six studies of about 3,300 patients with type 2 diabetes who were treated with dulaglutide as monotherapy, and in combination with other approved type 2 diabetes treatments, including metformin. It will be marketed as Trulicity by Eli Lilly.
The drug’s label has a boxed warning that thyroid C-cell tumors have been observed in rodent studies of dulaglutide, “but that it is unknown whether Trulicity causes thyroid C-cell tumors,” including medullary thyroid carcinoma (MTC) in humans, the statement said. It should not be used to treat patients who have had, or have, a family history of MTC, or in patients who have multiple endocrine neoplasia syndrome type 2, who are predisposed to MTC, the statement noted.
Eli Lilly is required to conduct several postmarketing studies, including a cardiovascular outcomes study in patients at a high risk of cardiovascular disease at baseline, a pediatric study, and a registry study of MTC cases to help determine whether there is an increase in the incidence of MTC associated with the use of the drug, for at least 15 years. Another postmarketing study will compare dulaglutide to insulin glargine for glycemic control in patients with type 2 diabetes and moderate or severe renal impairment.
Dulaglutide, a glucagon-like peptide-1 receptor agonist administered subcutaneously once a week, has been approved for treatment of adults with type 2 diabetes, the Food and Drug Administration announced Sept. 18.
It was approved with a Risk Evaluation and Mitigation Strategy (REMS) aimed at informing health care professionals about the serious risks of treatment and requirements for postmarketing studies that address some of those risks, the FDA said in a statement.
Approval was based on six studies of about 3,300 patients with type 2 diabetes who were treated with dulaglutide as monotherapy, and in combination with other approved type 2 diabetes treatments, including metformin. It will be marketed as Trulicity by Eli Lilly.
The drug’s label has a boxed warning that thyroid C-cell tumors have been observed in rodent studies of dulaglutide, “but that it is unknown whether Trulicity causes thyroid C-cell tumors,” including medullary thyroid carcinoma (MTC) in humans, the statement said. It should not be used to treat patients who have had, or have, a family history of MTC, or in patients who have multiple endocrine neoplasia syndrome type 2, who are predisposed to MTC, the statement noted.
Eli Lilly is required to conduct several postmarketing studies, including a cardiovascular outcomes study in patients at a high risk of cardiovascular disease at baseline, a pediatric study, and a registry study of MTC cases to help determine whether there is an increase in the incidence of MTC associated with the use of the drug, for at least 15 years. Another postmarketing study will compare dulaglutide to insulin glargine for glycemic control in patients with type 2 diabetes and moderate or severe renal impairment.
Dulaglutide, a glucagon-like peptide-1 receptor agonist administered subcutaneously once a week, has been approved for treatment of adults with type 2 diabetes, the Food and Drug Administration announced Sept. 18.
It was approved with a Risk Evaluation and Mitigation Strategy (REMS) aimed at informing health care professionals about the serious risks of treatment and requirements for postmarketing studies that address some of those risks, the FDA said in a statement.
Approval was based on six studies of about 3,300 patients with type 2 diabetes who were treated with dulaglutide as monotherapy, and in combination with other approved type 2 diabetes treatments, including metformin. It will be marketed as Trulicity by Eli Lilly.
The drug’s label has a boxed warning that thyroid C-cell tumors have been observed in rodent studies of dulaglutide, “but that it is unknown whether Trulicity causes thyroid C-cell tumors,” including medullary thyroid carcinoma (MTC) in humans, the statement said. It should not be used to treat patients who have had, or have, a family history of MTC, or in patients who have multiple endocrine neoplasia syndrome type 2, who are predisposed to MTC, the statement noted.
Eli Lilly is required to conduct several postmarketing studies, including a cardiovascular outcomes study in patients at a high risk of cardiovascular disease at baseline, a pediatric study, and a registry study of MTC cases to help determine whether there is an increase in the incidence of MTC associated with the use of the drug, for at least 15 years. Another postmarketing study will compare dulaglutide to insulin glargine for glycemic control in patients with type 2 diabetes and moderate or severe renal impairment.
