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ELN » Topics » FDA Review of Tysabri for the Treatment of Multiple Sclerosis

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


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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:
 
  •  On February 28, 2005, we and Biogen Idec announced the voluntary suspension of the commercialization and dosing in clinical trials of Tysabri, based on two reports of PML. PML is an opportunistic viral infection of the brain that usually leads to death or severe disability.
 
  •  We and Biogen Idec subsequently initiated a comprehensive safety evaluation of Tysabri and any possible link to PML. The safety evaluation was comprised of a complete review of all clinical trial data. We and Biogen Idec worked with clinical trial investigators and PML and neurology experts to evaluate more than 3,000 patients in MS, CD and RA trials. The safety evaluation also included a review of any reports of potential PML in patients receiving Tysabri in the commercial setting.
 
  •  In March 2005, we announced that the safety evaluation had led to a posthumous reassessment of PML in a patient in an open label CD clinical trial. The patient died in December 2003, and the case was originally reported by a clinical trial investigator as malignant astrocytoma.
 
  •  In August 2005, we reported that findings from the safety evaluation of Tysabri in patients with MS resulted in no new confirmed cases of PML beyond the three previously reported. In October 2005, we reported the same results from our evaluation of patients with CD and RA.
 
  •  In September 2005, we and Biogen Idec announced that we had submitted a supplemental Biologics License Application (sBLA) for Tysabri to the FDA for the treatment of MS and would submit a similar data package to the European Medicines Agency (EMEA). In November 2005, the sBLA was accepted and designated for Priority Review by the FDA, and the European submission was accepted for review.
 
  •  In February 2006, we and Biogen Idec were informed by the FDA that it had removed the hold on clinical trial dosing of Tysabri in MS in the United States.
 
  •  On March 8, 2006, the Peripheral and Central Nervous System Drug (PCNS) Advisory Committee voted unanimously to recommend that Tysabri be reintroduced as a treatment for relapsing forms of MS.
 
  •  On March 29, 2006, we and Biogen Idec announced the re-initiation of Tysabri clinical trial dosing in MS. Specifically, it was announced that the first patients were enrolled and dosed in the Tysabri monotherapy safety extension study program in MS.
 
  •  On April 28, 2006, we and Biogen Idec announced that the Committee for Medicinal Products for Human Use, the scientific committee of the EMEA, issued a positive opinion recommending marketing authorization for Tysabri as a treatment for relapsing-remitting MS to delay the progression of disability and reduce the frequency of relapses.
 
  •  On June 29, 2006, the EMEA approved Tysabri for the treatment of relapsing-remitting forms of MS.
 
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.
 
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