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Wednesday, January 15, 2014

Two High-Profile Multiple Sclerosis Treatments Receive Criticism From Governmental Drug Administrations

Jan 14, 2014

When it comes to drug development, the unmet need of crafting viable, effective Multiple Sclerosis treatments continues to be a major issue. The disease continues to increase throughout the world, with more than two million people presenting with some firm of MS. Most recently, two prominent treatments for Multiple Sclerosis received a vote of no-confidence from governmental drug administrations, indicating that the search for viable MS treatments still has a long way to go.
A report from last week indicated that the U.S. Food and Drug Administration rejected the Multiple Sclerosis treatment Lemtrada, on the basis that the drug has failed to demonstrate a high enough level of efficacy, particularly compared with its potential side effects and danger to the patient. Alemtuzumab, the generic name for the drug, is currently approved in the United States for the treatment for B-cell chronic lymphocytic leukemia (CLL). Used under the trade name under the Campath, even in this application, its use is highly limited for only “compassionate-care” situations. The drug is manufactured by Sanofi via its Genzyme production unit, which was pushing for the FDA to approve the drug for treatment for relapsing forms of MS. “Relapsing-Remitting Multiple Sclerosis” is often associated with the early onset of the disease.  The FDA argued that, particularly for this type of Multiple Sclerosis treatment designation, Lemtrada ”has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects,” and has called for a new round of clinical trials for the drug before it will be considered again for public use in the United States. Lemtrada (alemtuzumab) is currently approved in the EU and other countries as a Multiple Sclerosis treatment.


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