Pharmaprojects R&D Pipeline News Feed
Elan and Biogen Idec secure US approval for Crohn's disease therapeutic
18 Jan 2008
Elan Corporation and Biogen Idec have been granted US approval for their supplemental Biologics License Application regarding Tysabri (natalizumab) for the treatment of Crohn's disease. Tysabri's approved use will be for the induction and maintenance of clinical response and remission in adults suffering moderate-to-severe Crohn's disease who are refractory to conventional therapies and inhibitors of TNF-alpha, such as adalimumab and infliximab.
Gordon Francis MD, Senior Vice President of Global Clinical Development at Elan voiced his own approval, stating, "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".
Crohn's disease is a chronic and progressive inflammatory disease of the gastrointestinal tract which affects around 500,000 people inthe US alone. Diarrhoea and crampy abdominal pain, often associated with fever and rectal bleeding, can result. Tysabri has also received a negative opinion for Crohn's disease in the EU, with a final decision expected this quarter. The drug has had an eventful history, having been previously launched, voluntarily withdrawn and then relaunched for its primary indication, relapsing-remitting multiple sclerosis.
