Tysabri has 14,000 patients a year after re-launch

Share this article:

An estimated 14,000 patients across the globe are currently taking Elan and Biogen IDEC's multiple sclerosis treatment Tysabri, a year after the drug's return to market.

In the US, over 8,600 patients are on Tysabri and over 1,800 physicians have prescribed the therapy, the drug's marketers said. In the European Union, over 4,300 patients are on Tysabri therapy. An additional 1,000 patients are taking the drug in global clinical trials.

An FDA panel allowed Tysabri back on the market in June 2006 under a restricted distribution program. The agency ruled that Tysabri could only be prescribed, distributed and infused by healthcare providers registered with the “Tysabri Outreach: Unified Commitment to Health (TOUCH) prescribing program.” Before Tysabri treatment can start, patients must undergo a magnetic resonance imaging (MRI) scan. Then, patients on Tysabri are to be evaluated at three and six months after the first infusion, and every six months after that, with their status being reported directly to Biogen IDEC.

Tysabri was initially approved by the FDA in November 2004, but was withdrawn by Biogen Idec and Elan in February 2005, after three patients in the drug's clinical trials developed PML, a serious and rare viral infection of the brain. Based on this information, FDA put clinical trials of the drug on hold in February 2005.

FDA allowed a clinical trial of Tysabri to resume in February 2006, following a re-examination of the patients who had participated in the previous clinical trials, confirming that there were no additional cases of PML.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...

Xtandi duo boosts rep force for pre-chemo push

Xtandi duo boosts rep force for pre-chemo push

With its label extended to the pre-chemo setting, the prostate cancer drug is poised to reach a new group of urologists, and could upend J&J's Zytiga.