Avanir drug gets positive recommendation in EU
Avanir climbs after EU medicines panel says its drug Nuedexta should be approved
NEW YORK (AP) -- Shares of Avanir Pharmaceuticals Inc. jumped Friday after the company said a European regulatory group recommended approval of its drug Nuedexta.
The drug is already approved in the U.S. Being able to sell the drug in Europe would likely increase Avanir's revenues.
Avanir said a panel that advises the European Medicines Agency recommended Nuedexta be approved as a treatment for pseudobulbar affect. The European Commission often follows the panel's advice and generally decides whether to approve a drug a few months after the group's recommendation.
Pseudobulbar affect is a condition that involves involuntary emotional outbursts like laughing or crying. It is associated with brain disease or injury.
The FDA approved the drug in October 2010. In the company's latest quarter, revenue from Nuedexta rose 20 percent to $14.9 million.
Nuedexta makes up the bulk of Avanir's revenue, but the Aliso Viejo, Calif., company also receives royalty payments on sales of Abreva, a treatment for cold sores.
Shares rose 36 cents, or 11 percent, to $3.56 in morning trading. Shares had risen 22 percent in 2013.
