) diabetes candidate, Eperzan (albiglutide) has received a
positive opinion from the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP). A final
decision from the European Commission should be out by the end of
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The CHMP recommended the approval of Eperzan both as a
monotherapy and as combination therapy in adults suffering from
type II diabetes. The CHMP's positive recommendation was based on
encouraging data from eight phase III trials on Eperzan.
Eperzan is a long-acting glucagon-like peptide 1 (GLP-1) receptor
agonist being developed as a once-weekly treatment for type II
diabetes. We are encouraged with the CHMP recommendation on
Eperzan, which can provide an edge over daily dosing regime of
GLP-1 products including
) Victoza among others. Currently, Bydureon is the only GLP-1
receptor agonist which has once weekly dosing.
However, several big pharma companies like Novo Nordisk
Eli Lilly and Company
) (dulaglutide) have GLP-1 candidates with once weekly dosing in
Glaxo is also looking to get the drug approved in the U.S. as
well where a decision should be out by Apr 15, 2014. The review
period was extended by three months by the FDA to assess Glaxo's
response to the FDA's requests.
Glaxo carries a Zacks Rank #3 (Hold). In the near term, we
believe that investor focus will be on the release of its fourth
quarter and full year 2013 results (Feb 5). Some better-ranked
) carrying a Zacks Rank #2 (Buy).