Biogen Idec and Elan reintroduce TYSABR for the Treatment of Relapsing Forms of Multiple Sclerosis

25-Jul-2006

Biogen Idec and Elan Corporation, plc announced the commercial availability of TYSABRI(R) (natalizumab) for the treatment of relapsing forms of multiple sclerosis (MS) in the U.S. As previously announced, the U.S. food and Drug Administration (FDA) approved the supplemental biologics License Application (sBLA) for the reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of disability and reduce the frequency of clinical relapses.

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 (TOUCH Prescribing Program) designed to inform physicians and patients of the benefits and risks of TYSABRI treatment and minimize potential risk of progressive multifocal leukoencephalopathy (PML). Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies.

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. 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.

https://www.bionity.com/en/news/56570/biogen-idec-and-elan-reintroduce-tysabr-for-the-treatment-of-relapsing-forms-of-multiple-sclerosis.html