FDA News

FDA approves iDegLira combination injection

The FDA approved a New Drug Application for a fixed combination of insulin degludec and liraglutide for the treatment of type 2 diabetes, Novo Nordisk announced in a press release.

The once-daily drug, also known as iDegLira (Xultophy 100/3.6) is a combination of insulin degludec injection (Tresiba) and liraglutide (Victoza) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.

“Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals," Jakob Riis, executive vice president and head of North America operations, Novo Nordisk A/S, said in a statement. "Combining Tresiba and Victoza into a single injection will offer patients a new option that may help control their blood sugar. We look forward to making Xultophy 100/3.6 available to adults with type 2 diabetes in the first half of 2017.”

The drug’s approval is based on efficacy and safety data from the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL trials involving 1,393 adults with type 2 diabetes, patients who were inadequately controlled on liraglutide or basal insulin therapy and switched to iDegLira achieved reductions in HbA1c; patients with poorly controlled type 2 diabetes using basal insulin saw mean reductions in HbA1c of 1.67% and 1.94% when switched to iDegLira.

Common adverse events reported during the trials included nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.”

"I am excited for this new class of type 2 diabetes medication that can offer patients another treatment option to help them reach their goals," John Buse, MD, professor at the University of North Carolina School of Medicine, Chapel Hill, NC, and principal investigator for DUAL II, said in the statement.

IDegLira is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each 100/3.6 dosage unit contains one unit of insulin degludec and 0.036 mg of liraglutide. The starting dose is 16 units (16 units insulin degludec and 0.58 mg liraglutide); the maximum dose is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 in favor of an approval of iDegLira in May.

The FDA approved a New Drug Application for a fixed combination of insulin degludec and liraglutide for the treatment of type 2 diabetes, Novo Nordisk announced in a press release.

The once-daily drug, also known as iDegLira (Xultophy 100/3.6) is a combination of insulin degludec injection (Tresiba) and liraglutide (Victoza) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.

“Novo Nordisk is committed to discovering and developing new medicines, like Xultophy 100/3.6, that may make a difference in the way some adults with type 2 diabetes manage their diabetes and achieve their treatment goals," Jakob Riis, executive vice president and head of North America operations, Novo Nordisk A/S, said in a statement. "Combining Tresiba and Victoza into a single injection will offer patients a new option that may help control their blood sugar. We look forward to making Xultophy 100/3.6 available to adults with type 2 diabetes in the first half of 2017.”

The drug’s approval is based on efficacy and safety data from the DUAL (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes) clinical development program. In three DUAL trials involving 1,393 adults with type 2 diabetes, patients who were inadequately controlled on liraglutide or basal insulin therapy and switched to iDegLira achieved reductions in HbA1c; patients with poorly controlled type 2 diabetes using basal insulin saw mean reductions in HbA1c of 1.67% and 1.94% when switched to iDegLira.

Common adverse events reported during the trials included nasopharyngitis, headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.”

"I am excited for this new class of type 2 diabetes medication that can offer patients another treatment option to help them reach their goals," John Buse, MD, professor at the University of North Carolina School of Medicine, Chapel Hill, NC, and principal investigator for DUAL II, said in the statement.

IDegLira is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each 100/3.6 dosage unit contains one unit of insulin degludec and 0.036 mg of liraglutide. The starting dose is 16 units (16 units insulin degludec and 0.58 mg liraglutide); the maximum dose is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 in favor of an approval of iDegLira in May.