GlaxoSmithKline (GSK) has reported successful phase III trials of its new diabetes drug albiglutide, which it intends to file for regulatory approval.
The injectable drug, taken weekly, outperformed a rapid-acting insulin when used in combination with a daily insulin to manage type 2 diabetes.
Analysts predict the drug will earn GSK $250m per year by 2016 – not a potential ‘blockbuster’, but a robust product in the diabetes market.
Albiglutide – awaiting a new brand name after GSK dropped the name Syncria – is the latest product in the class of glucagon-like peptide-1 (GLP-1) diabetes drugs that includes Victoza from Novo Nordisk and Byetta from Amylin and Lilly.
GLP-1 drugs stimulate insulin release when glucose levels are high, a flexible property that makes them a potential alternative to insulin in patients with severe type 2 diabetes.
They have the further advantage of stimulating weight loss, which is of clinical value to most people with type 2 diabetes.
The first phase III trial of albiglutide, reported in November 2011, found it to be less effective than daily Victoza in reducing blood glucose levels – a disappointing result for GSK.
However, armed with top-line results from seven of eight phase III studies, GSK said that the cumulative data support an application for the drug’s approval as a treatment for type 2 diabetes.
One trial tested albiglutide against Lilly’s rapid-acting insulin Humalog when used in combination with Sanofi’s daily insulin Lantus.
The patients taking albiglutide experienced a 0.82 reduction in HbA1c, compared to 0.66 in the Humalog group. In addition, The albiglutide patients also lost an average of 0.73 kg in weight, whereas the Humalog patients gained 0.81 kg.
GSK expects to have all the data it needs to apply for regulatory approval by the end of 2012.