FDA Wants More Data on Valeant-Glaxo Epilepsy Drug

From Associated Press (December 1, 2010)


NEW YORK -- Valeant Pharmaceuticals International Inc. and GlaxoSmithKline PLC said Wednesday that the Food and Drug Administration did not approve their epilepsy drug candidate ezogabine.

The companies said the FDA cited "non-clinical reasons" in declining to approve ezogabine. They said they are reviewing the FDA's response to their application, and plan to answer the FDA in early 2011.

Ezogabine is designed for patients who are already using one to three other epilepsy drugs. It is intended for adult epilepsy patients with partial onset seizures.

Valeant and GlaxoSmithKline filed for FDA approval on Oct. 30, 2009. A standard FDA review takes 10 months, but the agency asked for an evaluation of the risks associated with the drug, and later extended its review by another three months.

Valeant is based in Mississauga, Ontario. GlaxoSmithKline is has headquarters in London.

Valeant shares rose $1.05, or 4.1 percent, to close at $26.92 Wednesday before the decision was announced. In aftermarket trading, the stock fell 77 cents, or 2.9 percent, to $26.15. Shares of GlaxoSmithKline rose 38 cents to $38.66 during the day and lost a penny to $38.65 in aftermarket trading.
 

Posted: December 2010


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