Tysabri Safety Review to be Completed by Late Summer
Date: Wednesday, April 27 @ 17:16:32 EDT
Topic: Tysabri (Antegren or Natalizumab)


Updated

Some news released within BiogenIdec's quarterly investor conference call today-- they have stated that the safety review for Tysabri is expected to be completed by the "late summer." They have also reiterated their stance that Tysabri is the most powerful MS treatment available and that they will let the investigation's results lead them as to if/what/how to re-market the therapy. Some quotes from BiogenIdec:

"We know that Tysabri is a very powerful therapy... Tysabri works very well and offers great hope for the MS community...

Our safety evaluation will help us answer some fundamental questions: What is the risk, who is at risk, and how do we mitigate that risk? We know through our discussions with patients and neurologists that they want to see Tysabri back on the market, so I'm hopeful that this will become a reality. But right now we need to let our safety evaluation conclude and decide the best path forward for Tysabri"

"It is our responsibility to ensure that patients and physicians are fully aware of the risks...of Tysabri. So while the benefits side of the equation of Tysabri is well understood... we must take the time necessary to better understand and explain the risks.

We are making very good progress in our assessments, and we expect to complete our analysis in late summer. At that time we will be able to begin discussions with the FDA about the appropriate path forward. Similarly we continue dialog with other regulatory authorities around the world."

Stay tuned... Elan's conference call is tomorrow.







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