Irish drugs firm Elan and its US partner Biogen Idec today announced the two-year anniversary of Tysabri (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS), marking the reintroduction of the product in the United States (US) and the first international approval. The companies estimate that as of the end of June 2008, more than 31,800 patients worldwide are receiving Tysabri treatment.
Specifically, as of the end of June 2008:
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In the US, more than 17,800 patients are on Tysabri commercially and more than 3,100 physicians have prescribed the therapy;
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Outside of the US, nearly 13,400 patients are on Tysabri commercially;
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In global clinical trials, more than 600 patients are on Tysabri; and,
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There have been no confirmed cases of progressive multifocal leukoencephalopathy (PML) since re-launch in the US and the first international approval in July 2006.
Cumulatively, in the combined clinical trial and post-marketing settings:
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More than 43,300 patients have been treated with Tysabri; and
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Of those patients, nearly 13,900 have received at least one year of Tysabri therapy and approximately 6,600 patients have been on therapy for 18 months or longer.
"Since beginning Tysabri therapy more than 18 months ago, I have experienced an improvement in my life and how I go about living with my MS every day," said patient Patricia Substelny. "The benefits have been significant in terms of reducing the number of exacerbations I have experienced. I can now confidently work in my garden, cook for my family and friends, and enjoy what life has to offer. I feel very fortunate to have Tysabri as an option to help me manage my MS."
In the two years since reintroduction in the US and the first international approval, the data continue to demonstrate the benefits of Tysabri treatment for patients with relapsing forms of MS. Data showed that Tysabri treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of Phase III clinical trials presented at this year's American Academy of Neurology annual meeting. In addition, new data from a patient-reported outcomes survey was presented at the Consortium of Multiple Sclerosis Centers annual meeting showing that after only three months of treatment with Tysabri, some patients reported improvements in overall quality of life, disease level, functional status and MS symptoms.
Along with Tysabri's well-established clinical efficacy, growing health economic data from across the globe has been presented and published endorsing the pharmacoeconomic benefits of Tysabri in MS patients. Based on this data, local health agencies in countries including Australia, Austria, the Netherlands, the United Kingdom, Sweden, France and Germany have all recommended Tysabri for reimbursement by government-run health agencies.
"During the past two years, my patients who are being treated with Tysabri appear to experience very positive benefits from the drug," said Dr. Thomas F. Scott, Professor of Neurology, Drexel University College of Medicine and Director, Allegheny MS Treatment Center in Pittsburgh."Many of my patients tell me Tysabri is helping them to regain control of their lives."
Elan's shares are down 2.79% in Dublin in early afternoon trading while the ISEQ Index is off 4.84%.
