Biogen, Elan receive FDA approval to reintroduce Tysabri for MS

New York, June 5 - Biogen Idec and Elan Corp. plc announced they received approval of their supplemental Biologics License Application to reintroduce Tysabri (natalizumab) for relapsing multiple sclerosis to slow the progression of disability and reduce the frequency of clinical relapses.

The Food and Drug Administration granted approval for reintroduction based on the review of Tysabri clinical trial data, revised labeling with enhanced safety warnings and a risk management plan designed to inform physicians and patients of the benefits and risks of Tysabri treatment and minimize potential risk of progressive multifocal leukoencephalopathy, the companies said.

Because of the increased risk of progressive multifocal leukoencephalopathy, Tysabri monotherapy is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate therapies.

The FDA also said it should not be used with other immune-system modifying drugs.

Tysabri will be available once the risk management plan is ready, including FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel.

A July launch is expected.

Tysabri was initially approved by the FDA in November 2004 but was withdrawn by the manufacturer, Biogen-Idec, in February 2005 after three patients in the drug's clinical trials developed progressive multifocal leukoencephalopathy, a serious and rare viral infection of the brain. Two of the cases were fatal.

Based on this information, FDA put clinical trials of the drug on hold in February 2005. The FDA allowed a clinical trial of Tysabri to resume in February 2006 following a re-examination of the patients who had participated in the previous clinical trials, confirming that there were no additional cases of progressive multifocal leukoencephalopathy.

Under the FDA requirements:

• Tysabri will only be prescribed, distributed and infused by prescribers, infusion centers and pharmacies registered with the program;

• Tysabri will only be administered to patients who are enrolled in the program;

• Before starting the therapy, health care professionals are to obtain the patient's Magnetic Resonance Imaging scan to help differentiate potential future multiple sclerosis symptoms from progressive multifocal leukoencephalopathy;

• Patients on Tysabri are to be evaluated at three and six months after the first infusion and every six months after that, and their status will be reported regularly to Biogen Idec.

Cambridge, Mass.-based Biogen develops products for oncology, neurology and immunology.

Elan is a neuroscience-based biotechnology company located in Dublin, Ireland.

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