Elan, one of Ireland's biggest pharma companies, has announced that it has gained approval to test it's Tysabri treatment for Multiple Sclerosis. If this drug is a success, it could mean up to 1.1BN additional revenue for Elan and partner company Biogen (source: http://www.forbes.com/feeds/ap/2008/01/17/ap4542688.html ). Here is the news story:
US approval for Elan’s Tysabri
Go ahead for controversial drug to treat Crohn’s disease
By Triona Doherty
Athlone-based company Elan have been given the go ahead this week to market their drug Tysabri in the US for the treatment of bowel disorder Crohn’s disease.
The US Food and Drug Administration (FDA) announced that they have approved Tysabri for adults with moderate to severe Crohn's disease, who have evidence of inflammation and have a poor response to, or cannot take, conventional therapies.
According to a statement from Elan, who produce the drug with Biogen Idec, it is anticipated that Tysabri will be available to Crohn's patients by the end of February 2008.
"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," a spokesperson for Elan said this week. "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 Prescribing Program for Crohn's patients."
At present Tysabri is marketed for the treatment of Multiple Sclerosis (MS), although it contains tight restrictions and a strong warning about a potentially fatal brain infection. The FDA have stipulated that Elan and Biogen Idec must put similar limits on sales of the drug for the treatment of Crohn’s disease. Patients will be given the opportunity to weigh up the risks versus potential benefits, while also agreeing to be monitored for problems.
Tysabri was initially approved by the FDA for the treatment of MS in November 2004 after a fast-track review process following promising early test results. Four months later, however, the drug was suspended after three cases of a rare and potentially fatal brain disease, progressive multifocal leukoencephalopathy (PML), emerged among patients.
In June 2006, the drug was given the all-clear and was reintroduced to the market, becoming only the second prescription drug ever to return to market in the US after being suspended for safety reasons.
Crohn's disease is a bowel inflammation causing crampy abdominal pain, often associated with fever, weight loss, and rectal bleeding. According to Elan, an estimated 500,000 people in the US have the disease.
Earlier this month Elan issued an update on the use of Tysabri in the treatment of MS, stating that 21,000 patients worldwide were using the drug on a commercial and clinical basis. No cases of the potentially fatal PML disease have occurred since the re-launch of the drug in 2006.
In Europe, however, regulators have so far failed to recommend the use of Tysabri for Crohn's disease. Elan and Biogen are expecting a final decision from the European Commission early this year.
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