GlaxoSmithKline (GSK) and Valeant Pharmaceuticals (VRX) recently submitted a response to the Complete Response Letter (CRL) received from the US Food and Drug Administration (FDA) for their epilepsy candidate, ezogabine.

The CRL, which was issued in Nov 2010, was for non-clinical reasons. We note that earlier, in August 2010, Glaxo and Valeant had received a positive recommendation from an FDA advisory panel regarding ezogabine. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had reviewed the safety and efficacy of the drug and voted unanimously in favor of ezogabine’s efficacy for the treatment of partial-onset seizures in adults where other treatments failed. However, later during the month, the FDA extended the review date for the candidate by three months.

Approved in the EU

Meanwhile, Glaxo and Valeant announced that the candidate received marketing approval in the EU in March 2011 under the trade name Trobalt. Glaxo and Valeant received marketing authorization for the use of Trobalt as an add-on treatment of partial onset seizures, with or without secondary generalization, in adults aged 18 years and above with epilepsy.

Approval was granted on the basis of data from two pivotal phase III studies, RESTORE 1 and 2, and one phase IIb study, Study 205. Results from these studies showed a 50% or more reduction in the frequency of seizures in patients being treated with Trobalt compared to patients on placebo.

The EU approval didn’t come as a surprise as earlier this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of Trobalt. Glaxo and Valeant had submitted the Marketing Authorization Application (MAA) for Trobalt to the EMA in November 2009.

Competition

Currently available epilepsy treatments include drugs like Pfizer Inc.’s (PFE) Neurontin and Lyrica, Glaxo’s Lamictal, and UCB’s (UCBJF) Keppra. We believe that ezogabine should be able to carve a niche for itself due to its differentiated mechanism of action.

We currently have Neutral recommendations on both Valeant and Glaxo.

 
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