Tysabri has been approved by the FDA for the treatment of moderate to severe Crohn's disease (CD) in patients who do not demonstrate an adequate response or can not tolerate other available therapies such as the anti-TNFs Remicade (infliximab) and Humira (adalimumab). The latest US approval adds to the initial multiple sclerosis (MS) approval that was granted by the FDA in November 2004. Elan and Biogen Idec are expected to launch Tysabri in the US for Crohn's disease towards the end of February 2008.
The development of Tysabri for CD was hampered when the drug was withdrawn from the market in February 2005 following several incidences of progressive multifocal leukoencephalopathy (PML). Tysabri was reinstated to the market for MS in July 2006 and by September 2007, no new cases of PML had been reported.
Although an FDA advisory committee recommended that Tysabri be approved for moderate to severe Crohn's disease in July 2007, it cautioned that further data were required before the risk of PML was acceptable in any subset of Crohn's disease patients. The approval of Tysabri for CD in the US will be accompanied by robust labeling and the condition that patients are monitored for PML under the mandatory TOUCH prescribing program, which is already in place for MS patients. Approval of Tysabri for CD in the EU remains uncertain as the EMEA ruled a negative opinion for the drug on two separate occasions during 2007.
Primary research carried out by Datamonitor suggests that Centocor's, Schering-Plough's and Tanabe's Remicade remains the first choice biologic therapy for CD. Moreover, it is estimated that most patients with CD who terminate therapy with Remicade are switched to treatment with Abbott's Humira (adalimumab), which was launched in the US for CD in May 2007, or will receive surgery. Tysabri will, therefore, be considered as a third-line treatment option for moderate to severe CD patients. Concerns over safety, lack of product familiarity and third-line therapy status will affect the uptake of Tysabri and the product is forecast to achieve CD-specific sales of around $40 million in the US by 2010. However, Tysabri is expected to achieve total brand sales of around $0.4 billion in the US by 2010.
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