FDA Approves GlaxoSmithKline's Tanzeum For Type 2 Diabetes
By Cyndi Root
GlaxoSmithKline (GSK) announced in a press release that the Food and Drug Administration (FDA) has approved Tanzeum (albiglutide). The subcutaneous injection is a once a week treatment for type 2 diabetes. The European Medicines Agency (EMA) recently approved the drug under the name Eperzan. GSK intends to launch Tanzeum in the U.S. in the third quarter of 2014. Vlad Hogenhuis, SVP and Head of the GSK Global Cardiovascular, Metabolic and Neurosciences Franchise said, “Many type 2 diabetes patients struggle to keep their blood sugar within the recommended levels. We are pleased that the approval of Tanzeum provides an effective new weekly GLP-1 treatment option for appropriate patients in the US.”
Tanzeum
Tanzeum (albiglutide) is a glucagon-like peptide-1 receptor agonist (GLP-1). People with type 2 diabetes often have reduced or absent production of GLP-1, an incretin hormone that reduces blood glucose levels. Tanzeum is considered an incretin mimetic as it mimics incretins to lower blood sugar. It stimulates the pancreas to release insulin in response to rising blood sugar and slows stomach emptying after eating, making the patient feel more satiated. Patients administer the drug once a week with an injector pen. Administration may be made at any time without regard to meals.
FDA Action
The FDA approved Tanzeum based on GSK’s Phase III Harmony studies of over 5,000 people. Over 2,000 people received Tanzeum while the rest received other type 2 diabetes drugs such as metformin, glimepiride, and pioglitazone. In a press release released by the FDA, the federal agency said that patients taking the drug showed an improvement in their HbA1c level (hemoglobin A1c or glycosylated hemoglobin), a measure of blood sugar control. The FDA is requiring post-marketing studies for pediatric patients, a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Tanzeum, and a cardiovascular outcomes trial (CVOT) to evaluate the cardiovascular risk of Tanzeum in patients with high baseline risk of cardiovascular disease.
Type 2 Diabetes
Type 2 Diabetes is a blood sugar disorder also known as hyperglycemia. The most prevalent type of diabetes, about 90 percent of all diabetes case, type 2 diabetes is when the body does not make enough insulin or uses insulin inefficiently. The condition is most often found in older adults, but young people are susceptible too. Without enough insulin, a person’s body cannot break down the sugar from food and damage can occur to the heart, kidneys, and eyes. Type 2 diabetes patients face a life-long and progressive disease often requiring the use of medication to control blood sugar levels.