9/25/2016
`
`2006 3» FDA Approves Resurned Marketing of Tysabri Under a Special Distribution Program
`
`Archived Content
`The content on this page is provided for reference purposes only. This content has not
`been altered or updated since it was archived.
`Search Archive
`
`Home3 News E1: Events“ Newsroom5 Press Announcementse’ 20067
`News & Events
`
`FDA NEWS RELEASE
`
`:3’6E7g“”E°IATE RELEASE
`June 5’ 2006
`
`Kimberly Rawlings, 301-827-6242
`Consumer Inquiries:
`888-INFO-FDA
`This press release was revised June 6, 2006, to clarify information in the first paragraph.
`
`Media Inquiries:
`
`patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations (flare-ups).
`Tysabri is indicated for use as monotherapy, because we don'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 MS.
`
`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 or
`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.
`
`Following a thorough review of Biogen-Idec's Risk Management Plan and proposed changes to its original
`marketing application, FDA determined that Tysabri can be made available under the TOUCH Program with the
`following main features:
`
`- The drug will only be prescribed, distributed, and infused by prescribers, infusion centers, and pharmacies
`registered with the program.
`
`- Prior to initiating the therapy, health care professionals are to obtain the patient's Magnetic Resonance
`Imaging (MRI) scan to help differentiate potential future multiple sclerosis symptoms from PML.
`- Patients on Tysabri are to be evaluated at 3 and 6 months after the first infusion and every 6 months after
`that, and their status will be reported regularly to Biogen Idec.
`More information, including a detailed product history, is available at
`www.fda.gov/cder/drug/infopage/natalizumab/default.htm.
`Biogen Idec is the manufacturer and Elan the distributor for Tysabri. Additional information on the TOUCH
`Prescribing Program is available from the companies by calling 1-800-456-2255.
`#
`
`RSS Feed for FDA News Releases“? [what is Rss?11]
`Page 1 of 2
`http:f!www.fda.gov/ ewsEvents/Newsroom/Press/Xnnouncements/2006lucm108662.htm
` r
`
`Coalition Exhibit 1062
`Coalition v. Biogen
`15_01
`
`U2
`
`Page 1 of 2
`
`Coalition Exhibit 1062
`Coalition v. Biogen
`IPR2015-01993
`
`

`

`9125/2016
`
`2006 > FDAApproves Resumed Marketing ofTysabri Under a Special Distribution Program
`
`and Players.
`
`Page Last Updated: 04/08/2013
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888—INFO—FDA (1—888—463-6332)
`Contact FDA
`- W 5 Q3 Q3
`‘i’:st.\_.g.o;».
`For Government For Press
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. /defau|t.htm
`
`4. /NewsEvents/defaulthtm
`
`5. /NewsEvents/Newsroom/default.htm
`
`6. /NewsEvents/Newsroom/PressAnnouncements/default.htm
`7. /NewsEvents/Newsroom/PressAnnouncements/2006/default.htm
`8. /NewsEvents/Newsroom/default.htm
`
`9. /NewsEvents/Newsroom/PressAnnouncements/default.htm
`10. /Aboutf-‘DA/ContactFDA/Staylnformed/RSSFeeds/PressReleases/rss.xm|
`11. ssLINK/ucm144575.htm
`
`Pa e20f2
`
`
`
`http:#www.fd3.gow'N sEvents/Newsroom/PressAnnouncemen%s/2006/ucm108662.htrn
`
`2/2
`
`Page 2 of 2
`
`