Albiglutide

Albiglutide

Clinical data
Trade names	Eperzan, Tanzeum
License data	EU EMA: Eperzan US FDA: Albiglutide
Pregnancy category	US: C (Risk not ruled out)
Routes of administration	Subcutaneous (SC)
ATC code	A10BX13 (WHO)
Legal status
Legal status	US: ℞-only
Pharmacokinetic data
Biological half-life	4-7 days
Identifiers
CAS Number	782500-75-8
ChemSpider	none
Chemical and physical data
Formula	C3232H5032N864O979S41
Molar mass	72,970 g/mol

Albiglutide (tradenames Eperzan and Tanzeum) is a glucagon-like peptide-1 agonist (GLP-1 agonist) drug marketed by GlaxoSmithKline (GSK) for treatment of type 2 diabetes. It is a dipeptidyl peptidase-4-resistant glucagon-like peptide-1 dimer fused to human albumin. The drug was invented by Human Genome Sciences and was developed in collaboration with GSK.^[1]

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).^{[2] [3]} 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. (NOTE that this information is out of date: exenatide is available as a weekly injection under the trade name Bydureon, which received FDA approval in January, 2012.)

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 remains 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.^[4]6 GSK filed for FDA approval on 01/14/2013 and European Medical Agency (EMA) on 03/07/2013. On 08/02/2013 GSK released a press release pushing the marketing date 3 months to 04/15/2014.

In March 2014, GlaxoSmithKline PLC received approval from the European Commission to market albiglutide under the name 'Eperzan'.^[5]

In April 2014, the FDA approved albiglutide under the name Tanzeum.^[6]

See also

• Glucagon-like peptide-1 analogs:

exenatide (Byetta)

liraglutide (Victoza)

taspoglutide

• DPP4 inhibitors
• Incretin

References

1. Matthew Herper for Forbes. 16 July 2012. Three Lessons From GlaxoSmithKline's Purchase Of Human Genome Sciences
2. 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.
3. Baggio; et al. (2008). "Glucagon-like Peptide-1 Analogs Other Than Exenatide".
4. "Phase III clinical trials of Albiglutide".
5. "Glaxo Gets EU Marketing Approval for Diabetes Drug Eperzan".
6. "FDA Approves Weekly Injectable Diabetes Drug: Albiglutide".