GlaxoSmithKline’s (GSK) 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 this quarter.
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 Novo Nordisk’s (NVO) 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 (semaglutide) and Eli Lilly and Company (LLY) (dulaglutide) have GLP-1 candidates with once weekly dosing in late-stage development.
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 stocks include Allergan (AGN) carrying a Zacks Rank #2 (Buy).
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