The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) decided on Friday to defer a decision on Laquinimod, an oral treatment for relapsing-remitting multiple sclerosis (RRMS). Laquinimod is being developed jointly by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Swedish company Active Biotech. According to Active Biotech, the EMA will issue an opinion at its January, 2014 meeting.
Press reports overseas state that the EMA spokesperson refused to provide further details, but said that the agency's experts were entitled to decide on a postponement of a decision of this kind if they saw a necessity to do so.
The future of Laquinimod is uncertain, since it failed to achieve the main endpoints in a clinical trial in 2011. The US Food and Drug Administration (FDA) has requested an additional Phase III trial before it will consider the companies' application to approve the product for sale.
Teva hopes that the drug will be launched in Europe in 2014. There are already several orally administered treatments for multiple sclerosis on the market, among them Biogene's Tecfidera, which analysts see becoming a blockbuster drug, with annual sales of $3 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on December 22, 2013
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