GlaxoSmithKline (GSK) and Valeant Pharmaceuticals (VRX) received good news recently in the form of EU approval for their epilepsy drug, Trobalt (retigabine). 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 doesn’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. Retigabine is referred to as ezogabine in the US.
US Status of Ezogabine
Trobalt’s EU approval comes as a boost for the companies, considering the complete response letter (CRL) issued by the US Food and Drug Administration (FDA) in December 2010 for the new drug application (NDA) of ezogabine.
The CRL was for non-clinical reasons and Valeant and Glaxo plan to file a response to the FDA in 2011.
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.
Competition
Currently available epilepsy treatments include drugs like Pfizer Inc.’s (PFE) Neurontin and Lyrica, Glaxo’s Lamictal, UCB’s Keppra and Johnson & Johnson’s (JNJ) Topamax. 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.
GLAXOSMITHKLINE (GSK): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
Zacks Investment Research
