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news.Elan Corporation and Biogen Idec have announced the approval of a supplemental biologics license application by the FDA for Tysabri, which is approved for for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease.
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Tysabri will be available for patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s disease (CD) therapies and inhibitors of TNF-alpha. The companies anticipate Tysabri will be available to Crohn’s patients by the end of February 2008.
Gordon Francis, senior vice president, global clinical development of Elan, said: “We are delighted that Tysabri will be available for Crohn’s patients and their physicians, who continue to need new therapeutic options with novel mechanisms of action. We are committed to providing therapeutic choice to those patients who can benefit from Tysabri, and will continue to work with the FDA and the medical community to implement the TOUCH (Tysabri Outreach: Unified Commitment to Health) prescribing program for Crohn’s patients.”