Back to top

Approval Delayed for Glaxo Drug

Read MoreHide Full Article

GlaxoSmithKline (GSK - Free Report) recently announced that the decision on the approval of its diabetes candidate, albiglutide, from the U.S. Food and Drug Administration (FDA) has been delayed by three months. A decision is expected to be out by Apr 15, 2014. The review period was extended by the FDA to assess Glaxo’s response to the FDA’s requests.  

We note that Glaxo submitted the marketing application for the candidate to the FDA in Jan 2013. The company is looking to get albiglutide, a glucagon-like peptide 1 (GLP-1) receptor agonist, approved for treating adults suffering from type II diabetes (once weekly).

In Mar 2013, Glaxo submitted a marketing application for albiglutide (proposed trade name: Eperzan) to the European Medicines Agency.

We note that the GLP-1 market is getting pretty crowded. While approved products include Novo Nordisk’s (NVO - Free Report) Victoza and Bristol-Myers Squibb’s (BMY - Free Report) Bydureon and Byetta, other companies also have GLP-1 candidates in late-stage development.

In recent quarters, Glaxo received approval for several drugs including two melanoma drugs, Tafinlar (dabrafenib) and Mekinist (trametinib) and chronic obstructive pulmonary disease drug, Breo Ellipta. Moreover, Glaxo boasts of a robust pipeline with a number of pipeline-related news is expected in the coming quarters.

However, the biggest near-term challenge for Glaxo will be to replace the revenues that will be lost to generic competition. Products like Valtrex, Lamictal, Imitrex, Requip, Combivir and Epivir are already facing declining sales due to intense generic competition.

Glaxo carries a Zacks Rank #3 (Hold). Companies that currently look attractive include Biogen Idec Inc. (BIIB - Free Report) , carrying a Zacks Rank #1 (Buy).

More from Zacks Analyst Blog

You May Like