The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) Tanzeum (albiglutide) subcutaneous injection to improve glycaemic control, along with diet and exercise, in adults with type 2 diabetes.
A glucagon-like peptide-1 receptor agonist (GLP-1), albiglutide is administered once-weekly using an injector pen supplied with a 5mm 29-gauge thin-walled needle.
Go deeper with GlobalData
GLP-1 is a major incretin hormone that helps in reducing blood glucose levels but, in people with type 2 diabetes, its production is often reduced or absent.
GSK senior vice-president and head of global cardiovascular, metabolic and neurosciences Franchise Vlad Hogenhuis 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," Hogenhuis added.
See Also:
The approval is based on the results of GSK’s Phase III Harmony programme, which includes eight trials involving more than 5,000 patients, of which at least 2,000 were treated with Tanzeum.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataIn these trials, albiglutide was evaluated 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.
FDA-approved Tanzeum through a risk evaluation and mitigation strategy (REMS) to ensure that the benefits of Tanzeum outweigh the potential risk of medullary thyroid carcinoma and the risk of acute pancreatitis.
Following FDA approval, the company expects to launch Tanzeum in the US in the third quarter of this year.
Last month, the European Medicines Agency (EMA) licensed albiglutide under the brand name Eperzan for use in adults with type 2 diabetes.
The drug is not recommended as first-line therapy for patients inadequately controlled on diet and exercise and it has not been studied in patients with a history of pancreatitis.
It is also not indicated for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
The drug has not been studied in patients with pre-existing severe gastrointestinal disease, as well as in combination with prandial insulin.
