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Xagena Newsletter

FDA has approved the reintroduction of Tysabri in relapsing multiple sclerosis

The FDA ( U.S. Food and Drug Administration ) has approved the reintroduction of Tysabri ( Natalizumab ) as a monotherapy treatment for relapsing forms of multiple sclerosis to slow the progression of disability and reduce the frequency of clinical relapses.

TYSABRI will be available upon the completion of key activities related to the risk management plan ( TOUCH Prescribing Program ), including FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel.

TOUCH Prescribing Program has been designed to inform physicians and patients of the benefits and risks of Tysabri treatment and minimize potential risk of progressive multifocal leukoencephalopathy.

Biogen Idec and Elan voluntarily suspended Tysabri from the U.S. market and all ongoing clinical trials in February 2005 based on reports of progressive multifocal leukoencephalopathy, an opportunistic viral infection of the brain that usually leads to death or severe disability.

TOUCH Prescribing Program

TOUCH ( TYSABRI Outreach: Unified Commitment to Health ) Prescribing Program was developed in conjunction with the FDA to facilitate the appropriate use of Tysabri and to assess, on an ongoing basis, the incidence and risk factors for progressive multifocal leukoencephalopathy, and other serious opportunistic infections associated with Tysabri treatment.

Elements of the TOUCH Prescribing Program include:

- Revised labeling with a prominent boxed warning of the risk of progressive multifocal leukoencephalopathy, and warnings against concurrent use of Tysabri with chronic immunosuppressant or immunomodulatory therapies, and patients who are immunocompromised due to HIV, hematological malignancies, organ transplants or immunosuppressive therapies

- Mandatory enrollment for all prescribers, central pharmacies, infusion centers and patients who wish to prescribe, distribute, infuse, or receive, respectively, Tysabri

- Controlled, centralized distribution only to authorized infusion centers

- Mandatory FDA-reviewed educational tools for patients and physicians, including a patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist

- Ongoing assessment of progressive multifocal leukoencephalopathy, risk and overall safety. A 5,000 patient cohort observational study over five years, the Tysabri Global Observation Program in Safety ( TYGRIS )

Two-year data from the AFFIRM monotherapy trial showed that treatment with Tysabri reduced the risk of disability progression by 42% ( p