Active Biotech, Teva to commence third Phase III study of laquinimod for RRMS

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Aug 9 2012

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) provided today an update on the clinical development program of once-daily oral laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS). The companies are to initiate a third Phase III study of laquinimod, following the written agreement reached with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA).

The third Phase III laquinimod trial CONCERTO will evaluate two doses of the investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24 months. The primary outcome measure will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

"The results achieved in the previous Phase III trials of laquinimod support the clinical utility of this compound as a unique treatment option for multiple sclerosis," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer, Teva Pharmaceutical Industries Ltd. "We are encouraged by the FDA's agreement on the trial design and planned analysis, and look forward to further developing laquinimod as a potential treatment option for RRMS patients."

Source:

Teva Pharmaceutical Industries Ltd.

Posted in: Drug Trial News | Medical Condition News

Tags: Biotechnology, Brain, Cancer, Cell, Compound, Crohn's Disease, Disability, Food, Generic Drug, Lupus, Medicaid, Medicare, Multiple Sclerosis, Nervous System, Neurodegeneration, New Drug Application, Oncology, Pain, Pharmaceuticals, Prostate Cancer, Protonix, Relapsing-Remitting Multiple Sclerosis, Respiratory, Sclerosis

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Where's The Beef?

Alan Stein says:

August 11, 2012 at 1:45 AM

I don't want to seem picky or unreasonable, but I have to say that the MS community is, by and large, a well-informed group of people who keep up with the latest research and for whom scientific details really matter.

So, when the rationale that is quoted for the continued development for Laquinimod is: "The results achieved in the previous Phase III trials of laquinimod support the clinical utility of this compound as a unique treatment option for multiple sclerosis", wouldn't it make sense for the article to describe what the Phase III results actually were??

Just another couple of sentences would have provided the information necessary to understand how well Laquinimod stacks up against other potntial therapies under the FDA review process. But, without it, this article is just another burger that is mostly an oversize bun with very little beef underneath.

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