Once-weekly Albiglutide Injection for Type 2 Diabetes Approved by FDA

April 15, 2014
HCP Live Staff

The US Food and Drug Administration has approved Tanzeum (albiglutide), a once-weekly subcutaneous injection for the treatment of type 2 diabetes in adults.

Tanzeum (albiglutide) injection has been approved by the US Food and Drug Administration to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.

The once-weekly subcutaneous injection was approved after being evaluated in 8 studies that involved more than 5,000 patients with type 2 diabetes, more than 2,000 of whom were treated with Tanzeum. According to a news release from GlaxoSmithKline, the studies “evaluated albiglutide against commonly-used classes of type 2 diabetes treatment… in patients at different stages of the disease, as well as those with renal impairment.” In the trials, patients showed improvement in their hemoglobin A1c (HbA1c) level.

Tanzeum is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is a hormone that assists in the normalizing of blood sugar levels. It can be used as a standalone treatment or in combination with other type 2 diabetes medications, including metformin, glimepiride, pioglitazone, and insulin.

“Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels,” Vlad Hogenhuis, Senior Vice-President and Head, GSK Global Cardiovascular, Metabolic and Neurosciences Franchise, said in a press release. “We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”

Tanzeum is not recommended for patients with type 1 diabetes, increased ketones, or as first-line therapy for patients who can’t be managed with diet and exercise. Side effects noted from the phase 3 trials include diarrhea, nausea, and injection site reactions.

Tanzeum will include a boxed warning on its label stating that “tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans,” according to the FDA announcement.

The FDA will require several postmarketing studies as a condition of approval, including a trial to evaluate safety and efficacy in children, an MTC case registry of at least 15 years, and a trial to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.

Tanzeum 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 Tanzeum.”