Biogen Idec, Elan say Tysabri available to treat relapsing forms of multiple sclerosis

By E. Janene Geiss

Philadelphia, July 24 - Biogen Idec and Elan Corp., plc announced Monday the commercial availability in the United States of Tysabri (natalizumab) for the treatment of relapsing forms of multiple sclerosis.

As previously announced, the Food and Drug Administration approved the supplemental Biologics License Application for the reintroduction of Tysabri as a monotherapy treatment for relapsing forms of multiple sclerosis to slow the progression of disability and reduce the frequency of clinical relapses, according to a company news release.

The FDA 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.

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

Under the Touch Prescribing Program, only prescribers, infusion centers and pharmacies associated with infusion centers registered in the Touch program are able to prescribe, infuse or distribute Tysabri, officials said.

Elan has contracted with a single distributor, ICS, a division of AmerisourceBergen Specialty Group, and 12 specialty pharmacies: Caremark, CuraScript, PharmaCare, PrecisionRx Specialty Solutions, Medmark, BioScrip, McKesson Specialty, Option Care, Cigna Tel-Drug Specialty Pharmacy, Aetna Specialty Pharmacy, Prescription Solutions and Accredo NovaFactor.

ICS and the 12 specialty pharmacies have been trained on the Touch Prescribing Program and are obligated to follow the requirements of the program in order to purchase and distribute Tysabri to authorized infusion sites and central pharmacies.

In addition, following the recent approval by the European Commission, the companies have introduced Tysabri in several countries in Europe.

Biogen Idec is a Cambridge, Mass., pharmaceutical company focused on oncology, neurology and immunology.

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

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