The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has confirmed its decision from January not to approve laquinimod, produced by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Active Biotech (Nasdaq: OMX, NORDIC: ACTI), for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the EU.
In January, the CHMP found that the risk-benefit profile of laquinimod was not positive. Teva and Active Biotech filed a request for a review of the finding. The result is a setback for the two companies, although neither Teva nor the market placed high hopes in the review process. Laquinimod has been considered a replacement for Teva's high-selling multiple sclerosis treatment Copaxone, the patent on which expired in the US yesterday.
In the US, laquinimod is even further from approval. Teva is currently carrying out a further trial of the drug, after a Phase 3 trial last year failed to reach one of the clinical endpoints except after a statistical adjustment. US Food and Drug Administration approval is therefore not expected soon.
In a statement, the companies said that they remained committed to the Nerventra (laquinimod) clinical development program for multiple sclerosis, and that they were focused on evaluating the CHMP feedback to determine potential next steps.
“We are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to multiple sclerosis patients in the EU,” said Michael Hayden, president of Global R&D and Chief Scientific Officer. “We believe Nerventra has a favorable risk-benefit profile and the potential to fulfill an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS.”
Published by Globes [online], Israel business news - www.globes-online.com - on May 25, 2014
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