Tuesday, June 14, 2011

Epilepsy Pill From Glaxo, Valeant Gets FDA Backing

LONDON—GlaxoSmithKline PLC and Canadian partner Valeant Pharmaceuticals International Inc. said Monday that their epilepsy pill Potiga was approved by U.S. drug regulators as an add-on treatment for partial onset seizures, which begin in one side of the brain.

The medicine, also referred to as ezogabine in the U.S., has been jointly developed by Glaxo and Valeant. It won marketing approval in the European Union at the end of March, where it is known under the brand name Trobalt.

Although the treatment initially won backing last August by a panel of experts advising the U.S. Food and Drug Administration, final approval was delayed when the FDA asked the manufacturers for more information on the product.

"We are so pleased to reach such an important milestone with the U.S. approval of Potiga by the FDA," Valeant head of research and development Susan Hall said in a statement. "We believe this product will play a needed role in the management of partial onset seizures in appropriate patients who are uncontrolled on their current medications."

Potiga is expected to be available in U.S. pharmacies by the end of the year. However, because the drug caused urinary retention in clinical trials, the FDA wants Glaxo and Valeant to compile a risk-evaluation and mitigation strategy for doctors to use when prescribing the treatment. Analysts say the product's sales potential looks fairly moderate.

Matrix pharmaceuticals analyst Navid Malik expects the drug to generate annual sales of up to $400 million by 2015, but said his projections are above those of some other observers.

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