The Food and Drug Administration (FDA) has approved albiglutide (Tanzeum, GlaxoSmithKline), a once-weekly injectable glucagonlike peptide 1 (GLP-1) receptor agonist to treat type 2 diabetes….
“Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes,” Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research is quoted in a press release. “It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
Albiglutide is indicated as monotherapy or in combination therapy with metformin, glimepiride, pioglitazone, or insulin.
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Albiglutide, a GLP-1 receptor agonist, is a biological product for the treatment of type 2 diabetes, administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle. GLP-1 is an important incretin hormone that helps reduce blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.
It is not indicated for patients with type 1 diabetes or diabetic ketoacidosis or as first-line therapy for patients who can’t be managed with diet and exercise.
The drug will also carry a boxed warning on its label stating that thyroid C-cell tumors have been observed in rodent studies with some drugs in this class but that it is unknown whether this particular drug causes these types of tumors, including medullary thyroid carcinoma (MTC), in humans.
Albiglutide should not be used in patients who have a personal or family history of MTC or have multiple endocrine neoplasia syndrome type 2 (which predisposes them to MTC).
The FDA is requiring postmarketing studies, including a trial to evaluate dosing, efficacy, and safety in pediatric patients; an MTC case registry of at least 15 years; and a cardiovascular-outcomes trial in patients with high baseline risk of cardiovascular disease.
The most common side effects in clinical trials of albiglutide were diarrhea, nausea, and injection-site reactions.
The FDA approved albiglutide with a risk evaluation and mitigation strategy (REMS), where the company has a communication plan to inform healthcare providers about the serious risks associated with it.
Albiglutide was approved last month in the European Union under the name Eperzan. In the US, it joins other GLP-1 agonists already on the market, including liraglutide (Victoza, Novo Nordisk) and exenatide (Byetta, AstraZeneca/Bristol-Myers Squibb). Another GLP-1 agonist waiting in the wings is Lilly’s dulaglutide.
The FDA approval of albiglutide is based on the results of GSK’s comprehensive Phase III Harmony program, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.
Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014.
FDA News Release, 4-15-2014