Tysabri
side effects, toxicity, safety, new approvals and uses     
About Tysabri
FDA approved an application for resumed marketing of Tysabri (natalizumab) subject to a
special restricted distribution program. Tysabri is a monoclonal antibody used to treat
patients with relapsing forms of multiple sclerosis to reduce the frequency of exacerbations
(flare-ups). Tysabri is indicated for use as monotherapy, because FDA doesn't know
enough about how its use with other immune modifying drugs could impact risk. It is also
meant for patients who have not responded adequately to, or cannot tolerate, other
treatments for multiple sclerosi.

Tysabri was initially approved by the FDA in November 2004, but was withdrawn by the
manufacturer, Biogen-Idec, in February 2005, after three patients in the drug's clinical trials
developed progressive multifocal leukoencephalopathy (PML), a serious and rare viral
infection of the brain. Two of the cases were fatal. 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 multifocal
leukoencephalopathy.

To decrease the possibility of patients developing multifocal leukoencephalopathy in the
future, while also making Tysabri available to appropriate multiple sclerosis patients, FDA
consulted in March 2006 with its Peripheral and Central Nervous Systems Drugs Advisory
Committee. The Advisory Committee recommended a risk-minimization program with
mandatory patient registration and periodic follow-up to identify as early as possible any
cases of multifocal leukoencephalopathy that may occur, and to try to determine the reason
the infection occurs. In response, Biogen-Idec, submitted to FDA a Risk Management
Plan, called the TOUCH Prescribing Program, to help ensure safe use of the product.

Biogen Idec is the manufacturer and Elan the distributor for Tysabri.

SOURCE FDA Approves Resumed Marketing of Tysabri Under a Special Distribution Program FDA News,
Questions and Answers June 5, 2006 [A1] Elan gets subpoena over Tysabri drug Reuters Tue Sep 29, 2009
11:46am EDT [A2] Phil Serafino Elan Says SEC Probes Tysabri, Bapineuzumab Disclosure (Update3)
Bloomberg.com Sept. 29 2009 [A3] US feds subpoena Elan for brain virus reports AP Sep 29, 2009 [A4] Peter
Loftus Elan Gets SEC Subpoena Over Tysabri Disclosures Wall Street Journal Sep 29, 2009
THIS WEBSITE TALKS ABOUT THE SIDE EFFECTS AND THE POTENTIAL HEALTH BENEFITS OF HERBS, SUPPLEMENTS,
PHYTONUTRIENTS AND DRUG PRODUCTS. THIS WEBSITE ALSO TALKS ABOUT SOME POPULAR HEALTH ISSUES AND DISEASES.
ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
DOCTOR IMMEDIATELY. ALL RIGHTS RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS.
Privacy Policy. ARTICLE INDEX
IMPORTANT NEWS

Elan Corp Plc said on Tuesday it received a U.S. Securities and Exchange Commission subpoena over its July 31,
2008 disclosure of two cases of an often fatal brain disorder tied to use of its Tysabri multiple sclerosis drug. Elan
said the subpoena also requests records and information about its July 29, 2008 discussion of clinical trial data
for its bapineuzumab drug intended to treat Alzheimer's disease. [A1]

Johnson & Johnson is paying $885 million for an 18.4 percent stake in Elan. In addition, J&J will acquire Elan’s
medicines against Alzheimer’s, including bapineuzumab. [A2]

The SEC is also seeking information on trial results for the company's experimental Alzheimer's drug
bapineuzumab, which were released last July. [A3] The full data presentation for bapineuzumab disappointed
many investors, who felt it was less impressive than the preliminary findings Wyeth and Elan had included in a
June 2008 press release. [A4]