Drug developer Eisai delivered a dose of good news and bad news on Tuesday, announcing plans to seek marketing approval for a new epilepsy drug but withdrawing such plans for an experimental sepsis treatment that failed in clinical trials.
Japan-based Eisai, which has its U.S. headquarters in Woodcliff Lake, New Jersey, and operates drug manufacturing facilities in North Carolina’s Research Triangle Park, said it would submit marketing authorization applications in the United States and the European Union for epilepsy compound perampanel. Eisai developed the compound to treat partial onset seizures in patients with epilepsy. The company said it plans to submit regulatory applications in the United States and Europe during the first quarter of its 2011 fiscal year.
But Eisai is pulling back its plans to seek marketing approval in the United States, Europe and Japan for sepsis drug candidate eritoran after the compound failed to perform better than a placebo in clinical trials.
Severe sepsis causes approximately 215,000 deaths each year in the United States ’ as many as heart attacks, and nearly as many as lung, colorectal and breast cancers combined. The mortality rate of patients with severe sepsis is approximately 30 percent. Worldwide, sepsis affects 18 million people every year.
Eisai said it will continue an analysis of the data from the clinical trials before determining its next steps. The company said it remains “committed to addressing critical areas of unmet need, such as sepsis.”
- GSK epilepsy drug gets European OK; U.S. regulators want more details (medcitynews.com)
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