The U.S. Food and Drug Administration (FDA) approved Jentadueto XR and an advisory committee voted unanimously in favor for the approval of IDegLira.
Jentadueto XR is an oral, once daily combination of linagliptin and metformin hydrochloride treatment for adults with type 2 diabetes. The medication combines 2.5 mg or 5.0 mg of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin with 1000 mg of metformin. The treatment is to be used in conjunction with diet and exercise.
The treatment has a boxed warning for the risk of lactic acidosis from metformin. People with type 1 diabetes or diabetic ketoacidosis should not use the treatment and the treatment has not been reviewed in people with a history of pancreatitis.
Jentadueto XR joins the market with other extended-release DPP-4 inhibitor/metformin combinations including Janumet XR and Kombiglyze XR.1-2
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 for the approval of IDegLira (insulin degludec and liraglutide). The FDA will continue to their review of the treatment and a decision regarding approval is expected by August.
The panel didn’t decide what subset of adults should be treated with IDegLira but did agree the treatment would be appropriate for adults who used an insulin analogue or GLP-1 agonist previously. The treatment should be used in conjunction with diet and exercise.
Before the advisory council met, concerns were raised over the uses of IDegLira and the interpretation of data from clinical trials. After meeting, the panel requested “reassurance that prescribers and patients would understand how to use the pen injector device” and better guidelines on the type of patient the treatment should be used.
At the panel, patients and clinicians urged for approval of the medication stating it was “safe and easy to administer” and hoped it would help decrease out-of-pocket costs.3-4
Jentadueto XR is marketed by Boehringer Ingelheim and Eli Lilly and Company and IDegLira is marketed by Novo Nordisk.
To read more about the approval of Jentadueto XR, visit the press release. For more information regarding the FDA panel approval for IDegLira, visit the advisory committee’s briefing document.
Eli Lilly and Company. U.S. FDA Approves Once-daily Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets for Adults with Type 2 Diabetes. PR Newswire. Published May 31, 2016 Accessed June 1, 2016.
Tucker M. FDA OKs Linagliptin/Metformin Combo for Type 2 Diabetes. Medscape. Published May 31, 2016 Accessed June 1, 2016.
Barber J. FDA advisory panel unanimously backs approval of Novo Nordisk's diabetes drug IDegLira. FirstWord Pharma. Published May 24, 2016. Accessed June 1, 2016.
Ault A. FDA Panel Backs Novo Nordisk Insulin–GLP-1 Combination IDegLira. Medscape. Published May 25, 2016. Accessed June 1, 2016.