This excerpt taken from the ELN 20-F filed Feb 28, 2007.
FDA Review of Tysabri for the Treatment of Multiple Sclerosis
In June 2006, the FDA approved the re-introduction of Tysabri for the treatment of relapsing forms of MS. Approval for the marketing of Tysabri in the European Union was also received in June 2006. The distribution of Tysabri in both the United States and European Union commenced in July 2006.
The FDA granted approval for the reintroduction of Tysabri based on the review of Tysabri clinical trial data, revised labeling with enhanced safety warnings, and a risk management plan called the Tysabri Outreach: Unified
Commitment to Health (TOUCH Prescribing Program), which is designed to inform physicians and patients of the benefits and risks of Tysabri treatment and minimize potential risk of PML. Under the TOUCH Prescribing Program, only prescribers, infusion centers and pharmacies associated with infusion centers registered in the TOUCH Prescribing Program are able to prescribe, infuse or distribute Tysabri. Elan has contracted with a single distributor and twelve specialty pharmacies to distribute product in accordance with the requirements of the TOUCH Prescribing Program.
The reintroduction of Tysabri was the culmination of a 17-month process and encompassed the following events:
In both the United States and Europe, special provisions are in place to ensure patients are informed of the risks of therapy and to enhance collection of post-marketing safety data and utilization of Tysabri in MS.