Arena will review its application to the European Medicines Union for Belviq, approved in the U.S. in June as the first new obesity drug in 13 years, before deciding when to resubmit it, the San Diego-based company said today in a statement.
The pill, being promoted in North America by Tokyo-based Eisai Co. (4523), works in a similar way to fenfluramine, part of the fen-phen appetite-suppression drug combination pulled from pharmacies in 1997 when it was linked to heart valve abnormalities. It will be available in the U.S. after the Drug Enforcement Administration completes a review to classify Belviq based on its potential for abuse.
Arena didn’t give a timetable for its application in Europe, saying it was “evaluating the best approach for submitting at a later date.”
Shares declined 14 percent to $7.25 in extended trading at 5:01 p.m. New York time after gaining 2.1 percent to close at $8.40.
Arena’s drug, previously known by its chemical name as lorcaserin, was rejected by the FDA in 2010 because the agency had concerns about cancer. Advisers to the agency determined the benefits of the drug outweighed the risks.
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