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Friday, December 20, 2013
EU postpones decision on Teva MS pill
December 20, 2013
LONDON (Reuters) - European regulators on Friday recommended approval of an innovative tuberculosis drug from Johnson & Johnson but postponed a keenly awaited decision on a new multiple sclerosis pill from Teva Pharmaceutical Industries.
The European Medicine Agency (EMA) said J&J's Sirturo, which was approved in the United States last December, had been endorsed as a treatment for multidrug-resistant tuberculosis.
The EMA had also been expected to decide this week on Teva's laquinimod, which the Israeli company is developing for multiple sclerosis with Swedish partner Active Biotech - but, in the event, this verdict was put off.
Active Biotech said it now expected the decision to come in January.
An EMA spokeswoman declined to give further details on the product but said the agency's experts could decide to postpone adoption of an opinion if deemed necessary, even when a drug was slated for a decision at a particular meeting.
Prospects for laquinimod are viewed by analysts as uncertain, since the drug missed its main goal in a late-stage trial in 2011 and U.S. regulators have asked for another Phase III study before considering it.