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Tuesday, December 17, 2013

EU agency due to give verdict on Teva (ORAL) MS pill this week

December 17, 2013
(Reuters) - European regulators are due to decide this week whether or not to recommend approval of a new multiple sclerosis pill from Teva Pharmaceutical Industries, according to a document published on Tuesday.
The European Medicines Agency, which has started publishing agendas for its scientific meetings, listed Teva's laquinimod among new medicines to be considered at the December 16-19 meeting of the Committee for Medicinal Products for Human Use (CHMP).

Decisions from the monthly meetings of the CHMP are normally made public on the following Friday, which would be December 20.
Israel's Teva has been developing laquinimod with Swedish partner Active Biotech but 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.
Despite that setback, Teva is still hoping to launch the drug in Europe in 2014. A green light from the CHMP this week would set it up for that, since recommendations are normally formally endorsed by the European Commission within a couple of months.
If it makes it, laquinimod will be entering an increasingly crowded marketplace, with rival oral treatments for multiple sclerosis already approved for companies such as Novartis, Biogen Idec and Sanofi.

(Reporting by Ben Hirschler; Editing by David Goodman) - 
source: uk.reuter.com 
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