GlaxoSmithKline has finally been given the green light in the USA to market its once-weekly diabetes drug albiglutide, which will be marketed as Tanzeum.
The US Food and Drug Administration has approved Tanzeum, a glucagon-like peptide-1 (GLP-1) receptor agonist, having extended its review period by three months last August. The thumbs-up is based on eight trials involving more than 2,000 patients and the drug has been studied as a stand-alone therapy and in combination with treatments such as metformin, glimepiride, pioglitazone and insulin.
Tanzeum comes with a boxed warning which notes that tumours of the thyroid gland have been observed in rodent studies with some GLP-1 receptor agonists. Also, the FDA stated that patients with a personal or family history of medullary thyroid carcinoma (MTC) should not use the therapy nor those with multiple endocrine neoplasia syndrome type 2 (where patients have tumours in more than one gland that predisposes them to MTC).
The agency is also insisting on post-marketing studies in children and a cardiovascular outcomes trial, plus an MTC case registry of at least 15 years duration.
How big an earner Tanzeum will be is debatable, given the very competitive GLP-1 market. The latter currently is dominated by Novo Nordisk’s once-a-day Victoza (liraglutide), AstraZeneca’s twice-daily Byetta (exenatide) and an extended-release formulation of the latter, Bydureon.
Regulators in Europe approved albiglutide last month, under the brand name Eperzan. It will be launched several countries in the Old Continent in the third and fourth quarters.
