MAA EU =marketing authorisation application EU
MAR 08 2013
GlaxoSmithKline has announced the submission of a marketing authorisation application for albiglutide, which will have the brand name Eperzan, to the European Medicines Agency.
The filing of albiglutide, a once-weekly treatment for type 2 diabetes, comes almost two months after it was filed in the USA. The drug is a GLP-1 receptor agonist, the same class of injectable treatments dominated by Novo Nordisk’s once-a-day Victoza (liraglutide), twice-daily Byetta (exenatide) and an extended-release formulation of the latter, Bydureon. They were developed and sold by Amylin, which was then acquired by Bristol-Myers Squibb and AstraZeneca.
The filing is based in part on a study which assessed albiglutide against Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin) which showed that GSK’s drug showed clinically and statistically significant reductions in HbA1c from baseline and superiority versus the US firm’s diabetes blockbuster. However in data from a late-stage study released in November 2011, albiglutide failed to show non-inferiority to Victoza and a number of analysts believe GSK will have its work cut out to grab a decent share of the GLP-1 market.
Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist) drug under investigation by GlaxoSmithKline for treatment of type 2 diabetes. It is a dipeptidyl peptidase-4-resistant glucagon-like peptide-1 dimer fused to human albumin.
Albiglutide has a half-life of four to seven days, which is considerably longer than the other two GLP-1 analogs approved for market use, exenatide (Byetta) and liraglutide (Victoza).  GLP-1 drugs are currently only available for subcutaneous administration on a daily basis, so a GLP-1 drug with a longer half-life is desirable. Such a drug would only need to be injected biweekly or weekly instead of daily, reducing the discomfort and inconvenience of GLP-1 administration considerably.
It has not yet been determined whether albiglutide is as effective an antidiabetic agent as GLP-1 drugs currently on the market, and final data remain to be published regarding the incidence of adverse effects related to the drug. To evaluate the efficacy and safety of the drug, albiglutide is undergoing eight Phase III clinical trials. Four of these trials should report useful data by end 2010.
- Matthews JE, Stewart MW, De Boever EH, et al. (December 2008). “Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Albiglutide, a Long-Acting Glucagon-Like Peptide-1 Mimetic, in Patients with Type 2 Diabetes”. J. Clin. Endocrinol. Metab. 93 (12): 4810–4817. doi:10.1210/jc.2008-1518. PMID 18812476.
- Baggio et al. (2008). “Glucagon-like Peptide-1 Analogs Other Than Exenatide”.
- “Phase III clinical trials of Albiglutide”.