FDA Agrees to Priority Review for Tysabri®

National Multiple Sclerosis Society website ^ | November 18, 2005 | National Multiple Sclerosis Society

[Magnolia]

The sponsors of Tysabri (natalizumab), Biogen Idec and Elan Corporation, announced today that the U.S. Food and Drug Administration has agreed to conduct a “Priority Review” of their application to return the drug back to the market. Tysabri was withdrawn in February 2005 due to safety concerns and is currently being re-evaluated by the FDA. (Read background information about Tysabri.)

Agreeing to a Priority Review means that the FDA has approximately six months from the late September 2005 submission date to review the safety and efficacy data submitted by the companies, to seek advice from experts and comments from persons who have MS, and to reach a decision about whether the drug can return to market. That suggests that by late March 2006 the FDA will make its decision.

The FDA would like to hear from individuals who have MS about how they feel about Tysabri. If you or someone you know has MS and would like to express your opinion about Tysabri, contact:

Mail: Office of Special Health Issues Food and Drug Administration HF-12, Room 9-49 5600 Fishers Lane Rockville, MD 20857

Phone: (301) 827-4460 or toll-free 888-INFOFDA (888-463-6332)

Fax: (301) 443-4555

E-mail: OSHI@oc.fda.gov

Note: The Office of Special Health Issues cannot comment on the status of a product undergoing FDA review. They are also not the place to request information about adverse events or product problems. You may visit MedWatch area on the FDA's Web site for information about reporting these events.

[Magnolia]

I received the link to this bulletin from the OK NMSS Chapter. For a while Tysabri seemed to be the answer to many prayers. We'll see what happens now...

[Magnolia]

Pinging MS list....

[cgk]

MS Ping!

Please FReepmail me if you would like to be added to, or removed from, the (new!) Multiple Scleroris ping list!

**Happy Thanksgiving! Will be back after this weekend.**

[2ndClassCitizen]

If there is an MS list, please add me to it.

[cgk]

Welcome aboard! :)

[Magnolia]

Thanks for pinging the list cgk. Glad to see you 2CC...tell us about yourself.

[Magnolia]

BUMP

[2ndClassCitizen]

I am married to a wonderful lady who was diagnosed with MS about a year and a half ago. Since, life has changed. I now realize that some of the things I took for granted are not there anymore. But she is, and I appreciate her and love her more than ever before.

Sorry, it took awhile to reply. Please add me to your list, if you have one. The cure is coming, we just have to keep hope and hang on until it does.

[2ndClassCitizen]

Almost forgot, the red HOPE band, it is on wrist always. Never give up on HOPE!

[2ndClassCitizen]

Jeaneen and I are doing fine. She had a particularly nasty exacerbation. Aren't they all?

Thank you for your prayers, things are working better for us now.

I heard about the fires, hope you were not affected.

[RXSalesman]

Did you see that the FDA announced on friday the long awaited Advisory panel to discuss the potential return of Tysabri? It is scheduled for March 7th. http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d030706.html The CEO of Tysabri's maker is confident as ever that Tysabri demand will be as big as they initally thought. In speeches before investors earlier this month, Kelly Martin indicated they have many MS patients on the list to start Tysabri therapy once the FDA gives the go-ahead. He actually stated that they've gotten reports from MS patients who were involved in the clinical trials who because of Tysabri were able to abandon their walkers/ wheelchairs, even to the point of enjoying bike-riding again.