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Glaxo Seeks EU Approval for Eperzan

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GlaxoSmithKline (GSK) recently announced the submission of a marketing application to the European Medicines Agency (:EMA) for its diabetes candidate Eperzan (albiglutide). The company is looking to get the candidate approved for treating adults suffering from type II diabetes (once weekly).

A few weeks back, in Jan 2013, Glaxo had submitted a Biologics License Application (:BLA) for Eperzan to the US Food and Drug Administration (:FDA) seeking approval for the above mentioned indication.

The marketing application includes data from a phase III study (Harmony 8). We note that in Jul 2012, Glaxo had reported encouraging results from the Harmony 8 study, which evaluated Eperzan versus Merck’s (MRK) Januvia (sitagliptin).

Approximately 507 type II diabetes patients with renal impairment were enrolled in the study. The drugs were compared on the basis of reduction in HbA1c, an indicator of glucose level in the blood.

Eperzan showed a statistically significant reduction in HbA1c from the baseline. Results showed that reduction in HbA1c in the Eperzan and Januvia arms were 8.08% and 8.22%, respectively. Additionally, the rate of weight loss was higher in the Eperzan arm.

Glaxo boasts a strong late-stage pipeline. The company is already seeking approval for several candidates including Relvar/Breo (chronic obstructive pulmonary disease/COPD and asthma), Anoro (:COPD), dolutegravir (:HIV), dabrafenib (oncology) and trametinib (oncology).

We are positive on the advancement of Glaxo’s pipeline programs. We believe the candidates hold immense commercial potential.

Glaxo carries a Zacks Rank #4 (Sell). Large-cap pharma companies that currently look better-positioned include Eli Lilly and Company (LLY) and Novo Nordisk (NVO). Both are Zacks Rank #2 (Buy) stocks.

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