Natalizumab: profile and news






PRESCRIPTION DRUGS: A CHOICE BETWEEN SAFETY AND LIFE  07 Mar 2006
Costs Lives," Wall Street Journal, March 2, 2006; based upon: Chris H. Polman et al., "A Randomized, Placebo-Controlled Trial of Natalizumab for Relapsing ... - National Center for Policy Analysis,

Evaluation of Patients Treated With Natalizumab (Tysabri) Finds No ...  Mar 2, 2006
BETHESDA, MD -- March 2, 2006 -- An independent clinical and laboratory study of more than 3000 people treated with the drug natalizumab (Tysabri®) for ... - DG News

Evaluation of patients treated with natalizumab finds no new cases ...  Mar 2, 2006
An independent clinical and laboratory study of more than 3000 people treated with the drug natalizumab (Tysabri®) for multiple sclerosis (MS), Crohn’s ... - Innovations-Report,

Fatal flaw in natalizumab, multiple sclerosis drug, trial  Mar 2, 2006
...would do fine without the drug. The drug in question is natalizumab, which has the brand name of Tysabri. In November 2004, the US ... - RxPG NEWS,

Evaluation of Patients Treated with Natalizumab for Progressive ...  Mar 1, 2006
Background Progressive multifocal leukoencephalopathy (PML) was reported to have developed in three patients treated with natalizumab. ... - New England Journal of Medicine (subscription),

Anti-inflammatory Drug's Potentially Deadly Side Effect Found To ...  Mar 5, 2006
Scientists have completed an extensive study of more than 3,000 patients who received a promising anti-inflammatory drug, natalizumab, that was linked to three ... - Medical News Today (press release),

Evaluation of patients treated with natalizumab finds no new cases ...  Mar 2, 2006
An independent clinical and laboratory study of more than 3000 people treated with the drug natalizumab (Tysabri®) for multiple sclerosis (MS), Crohn's disease ... - PressZoom (press release),

Evaluation of Patients Treated With Natalizumab Finds No New Cases ...  Mar 2, 2006
Natalizumab, an immune system-modifying drug, was approved by the US Food and Drug Administration in November 2004 to treat relapsing-remitting MS. ... - PharmaLive.com (press release),

A Randomized, Placebo-Controlled Trial of Natalizumab for ...  Mar 1, 2006
Background Natalizumab is the first 4 integrin antagonist in a new class of selective adhesion-molecule inhibitors. We report the ... - New England Journal of Medicine (subscription),

Natalizumab plus Interferon Beta-1a for Relapsing Multiple ...  Mar 1, 2006
Natalizumab, an 4 integrin antagonist, appeared to be safe and effective alone and when added to interferon beta-1a in preliminary studies. ... - New England Journal of Medicine (subscription),

Lessons from natalizumab fast tracking in multiple sclerosis  Feb 17, 2006
It follows approval of natalizumab, a new drug for multiple sclerosis, and its recall three months later, after three trial patients developed a life ... - RxPG NEWS,

FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment ...  Feb 16, 2006
...that Biogen-IDEC and Elan Corporation announced yesterday that FDA removed the clinical hold on Biogen-IDEC's studies of Tysabri (natalizumab) for patients ... - FDA.gov

Do Over: New MS drug may be safe after all  Mar 3, 2006
Journal of Medicine. The drug, natalizumab, was pulled 4 months after its approval by the Food and Drug Administration. Three patients ... - Science News

Tysabri Studies Suggest MS Efficacy May More than Balance PML Risk  Mar 1, 2006
AMSTERDAM, March 1 - Although the promising multiple sclerosis drug Tysabri (natalizumab) was pulled from the market in 2005 for safety concerns, an initiative ... - MedPage Today,

Tysabri effective for MS but carries some risk  Mar 1, 2006
However, a review of more than 3000 patients treated with Tysabri (which is known as natalizumab, generically) in clinical trials revealed that the drug is ... - Olberlin,

Tysabri retards progression of multiple sclerosis: trials  Mar 2, 2006
Tysabri, a drug generically known as natalizumab that was pulled off the market after three users developed a serious brain condition, decreases the rate of ... - Earthtimes.org

Potential risks of powerful MS drug are weighed  Mar 2, 2006
Natalizumab (branded Tysabri), made by Biogen Idec and Elan Pharmaceuticals, reduced the risk of sustained progression of disability from MS by 42% in a study ... - New Scientist (subscription),

New studies highlight the benefit of anti-MS drug  Mar 2, 2006
Another recent therapy, natalizumab, was showing promise before being voluntarily withdrawn from the market in 2005 due to concerns over patients developing ... - Ars Technica,

New Drug Reduces MS Relapse  Mar 1, 2006
Researchers found the new drug, Natalizumab reduces the risk of sustained progression of disability by 42-percent over two years. ... - Ivanhoe,

Tysabri® Two-Year Phase III Multiple Sclerosis Clinical Trial ...  Mar 5, 2006
Elan Corporation, plc (NYSE: ELN) announced today that two-year results from the two Phase III clinical trials evaluating TYSABRI® (natalizumab) for patients ... - Medical News Today (press release),

In Major Ruling, Massachusetts Court Orders Biogen to Produce ‘ ...  Feb 25, 2006
...patients developed progressive multifocal leukoencephalopathy (PML), a frequently fatal infection of the brain, two following treatment with natalizumab for MS ... - Newsinferno.com,

Elan's Tysabri monotherapy cuts MS progression-journal  Mar 1, 2006
The results also showed that treatment with Tysabri, whose generic name is natalizumab, led to a 68% reduction in the annualized relapse rate compared with the ... - MarketWatch

Withdrawn multiple sclerosis drug is safe -studies  Mar 1, 2006
...market. The drug, also known by the generic name natalizumab, was removed by Biogen Idec Inc. and its marketing partner Elan Corp. ... - Reuters AlertNet,

Pulled MS drug found safe in two studies  Mar 1, 2006
...back on the market. The drug, also known by the generic name natalizumab, was removed by Biogen Idec Inc. and its marketing partner ... - Newsweek

Controversial MS Drug Trial Flawed, Experts Say  Mar 3, 2006
...penned by Stanford University neurologists Dr. Annette Langer-Gould and Dr. Lawrence Steinman, adds fuel to the debate over Tysabri (natalizumab), which has ... - Forbes

Inflation Fears Linger  Mar 3, 2006
Tysabri, which's chemical name is natalizumab is used to treat patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical ... - Trading Markets,

AUDIO SUMMARY  Mar 1, 2006
Featured are articles on natalizumab alone and in combination with interferon for relapsing multiple sclerosis, evaluation of patients treated with natalizumab ... - New England Journal of Medicine (subscription),

Alarm over drugs fast-tracking  Feb 16, 2006
He reflects on the recent approval granted to multiple sclerosis treatment natalizumab and its subsequent withdrawal over health fears. ... - DeHavilland,

Geons, Black Holes, and Quantum Foam: A Life in Physics  Mar 3, 2006
2, 2006) — Scientists have completed an extensive study of more than 3,000 patients who received a promising anti-inflammatory drug, natalizumab, that was ... - Science Daily (press release)

Two-Day Tysabri Hearing Drawing Intense Attention  Mar 3, 2006
But recent developments indicate that the FDA might allow the developers of Tysabri (natalizumab), Biogen Idec Inc. and Elan Corp. ... - BioWorld Online (subscription),

Biotech's Mid Caps Post Solid Gain in February  Mar 1, 2006
...world was rattled by the startling news that Biogen Idec and partner, Elan were pulling their new drug for multiple sclerosis, Tysabri (natalizumab) from the ... - PR Newswire (press release),

Studies Suggest Controversial Multiple Sclerosis Drug Is Safe  Mar 1, 2006
Three patients taking the drug, Tysabri (generic name natalizumab) had developed progressive multifocal leucoencephalopathy (PML), a progressive ... - Forbes

Elan cites positive results from 2-yr Phase III trial on Tysabri ...  Mar 2, 2006
PLC and Biogen Idec Inc said they have had positive two-year results from the two Phase III clinical trials evaluating TYSABRI (natalizumab) for patients with ... - Forbes

Multiple Sclerosis Drug Tysabri Showed Promise - MS Sufferers Ask ...  Mar 2, 2006
Stanford researchers have found that the new drug natalizumab (Tysabri) can have fatal consequences. The drug went through the US ... - Best Syndication,

Multiple sclerosis drug might go back on market  Mar 2, 2006
Rudick's study was one of two whose initial positive results led the FDA to approve Tysabri, also known as natalizumab, in the first place. ... - Cleveland Plain Dealer,

New Clinical Trial Results on TYSABRI  Mar 2, 2006
Biogen Idec and Elan Corporation announced that two-year results from the two Phase III clinical trials evaluating TYSABRI (natalizumab) for patients with ... - Playfuls.com,

Interactive Children's Workshop, Educational Events, and Community ...  Mar 1, 2006
2006, MSAA's president and CEO Doug Franklin will be speaking at the Food and Drug Administration's public forum concerning Tysabri(r) (natalizumab), which was ... - PrimeZone (press release),

FDA Extends Tysabri Meeting By One Day, Removes Clinical Hold  Feb 17, 2006
FDA based its decision on the safety evaluation conducted by the companies of more than 3,000 patients who had received natalizumab in clinical studies under ... - FDA Advisory Committee

Two studies of Tysabri see little risk  Mar 2, 2006
The drug, also known by the generic name natalizumab, was removed by Cambridge-based Biogen Idec Inc. and its marketing partner Elan Corp. ... - Boston Globe,

Genentech, Biogen Idec Gain Approval Of Rituxan In RA  Mar 1, 2006
Biogen Idec, the next big company event is scheduled for next week when an FDA advisory committee meets to consider whether Tysabri (natalizumab) can return to ... - BioWorld Online (subscription),

FDA Lifts Hold On Clinical Trials Of Tysabri  Feb 17, 2006
...(AHN) - The Food and Drug Administration has removed the clinical hold on Biogen-IDEC's studies of Tysabri (natalizumab) for patients with multiple sclerosis. ... - All Headline News

Schering AG: Set for Betaseron Buy-Back Boost  Feb 22, 2006
...near term, although with the FDA ruling that Biogen Idec and Elan Corporation can resume clinical trials of rival drug Tysabri (natalizumab), Betaseron could ... - International News Service,

Commercialization of drugs by fast tracking is a cause of concern  Feb 17, 2006
...purposes. This has come after natalizumab, a new drug for multiple sclerosis, was approved and thereafter recalled after three months. ... - MedIndia,

Tysabri® Multiple Sclerosis Clinical Trial Hold Lifted By FDA ...  Feb 19, 2006
...the Food and Drug Administration (FDA) informed the companies that they have removed the hold on clinical trial dosing of TYSABRI® (natalizumab) in multiple ... - Medical News Today (press release),

FDA Approved Controversial MS Drug Too Quickly: Expert  Feb 17, 2006
But the author of the BMJ article believes Tysabri -- whose generic name is natalizumab -- was approved too quickly in the first place. ... - Forbes

FDA Allows Withdrawn MS Drug to Return in Clinical Trial  Feb 17, 2006
17 (HealthDay News) -- The US Food and Drug Administration announced Thursday that it has approved the clinical trial use of Tysabri (natalizumab), a multiple ... - Forbes

Tysabri trials hold lifted by the FDA  Feb 16, 2006
...have recieved word from the Food and Drug Administration (FDA) that the hold has been removed on clinical trial dosing of Tysabri (natalizumab) in multiple ... - Boston Mass High Tech,

Biogen and Elan to resume Tysabri trial  Feb 17, 2006
Now that the hold on clinical trial dosing of Tysabri (natalizumab) in multiple sclerosis (MS) has been removed, the companies expect to begin a multi-center ... - Pharmaceutical Business Review

Biogen Idec Reports Full Year and Fourth Quarter 2005 Results  Feb 15, 2006
...have received notification from the FDA that the Peripheral and Central Nervous System Drugs Advisory Committee will review TYSABRI(R) (natalizumab) for the ... - Genetic Engineering News,

It is Believed that Natalizumab's Efficacy in the Treatment of ...  Jan 27, 2006
...the development of three cases of a rare opportunistic infection in patients taking Biogen Idec and Elans monoclonal antibody (MAb) natalizumab (Tysabri), the ... - Business Wire (press release),

Flat sales in Q4 for Serono; no word on buyer  Feb 6, 2006
And Rebif could see increased competition later this year if Biogen Idec and Elan's withdrawn MS drug Tysabri (natalizumab) returns to the market. ... - Pharma Times (subscription),

Largest Industry Conference on Inflammatory Diseases to Feature ...  Jan 25, 2006
The agenda offers the latest clinical updates on Tysabri® (natalizumab), Daxas® (roflumilast), PI3K for RA, LFA-1 Inhibition, H4 Receptors for Allergy, Src ... - Yahoo! News (press release)

Elan cuts losses; earmarks funds for Tysabri return  Jan 31, 2006
...operating result was well down on the $98 million loss posted in the same period of 2004, and even in the absence of Tysabri (natalizumab), product revenue ... - Pharma Times (subscription),

Multiple Sclerosis Treatment, Notification Of FDA Advisory ...  Jan 29, 2006
...the US Food and Drug Administration (FDA) that the Peripheral and Central Nervous System Drugs Advisory Committee will review TYSABRI® (natalizumab) for the ... - Medical News Today (press release),

Elan meldt financiële resultaten vierde kwartaal en hele jaar ...  Jan 31, 2006
Research & Development Tysabri (Natalizumab) As previously announced, the supplemental Biologics License Application (sBLA) for Tysabri for the treatment of MS ... - Netherlands Corporate News (persbericht),

Biogen Idec and Elan Announce Notification of FDA Advisory ...  Jan 22, 2006
US Food and Drug Administration (FDA) that the Peripheral andCentral Nervous System Drugs Advisory Committee will review TYSABRI(R)(natalizumab) for the ... - Finanzen.net,

10th Anniversary Summit on Inflammatory & Immune Diseases to ...  Jan 11, 2006
MD, Ph.D. Professor, Department of Medicine Division of Clinical Immunology & Rheumatology UNIVERSITY OF ALABAMA BIRMINGHAM Natalizumab, Clinical Effects of ... - PR Newswire (press release),

Approval to restart Phase IIa trial in MS patients  Jan 12, 2006
On November 17, 2005 Biogen and Elan announced that "the supplemental Biologics License Application (sBLA) for Tysabri® (natalizumab) for the treatment of ... - Biotech Intelligence (press release),

Elan Corp and Biogen Idec Receive FDA Notification  Jan 23, 2006
...the US Food and Drug Administration (FDA) that the Peripheral and Central Nervous System Drugs Advisory Committee will review TYSABRI(R) (natalizumab) for the ... - New Age Media Concepts (press release)

Biogen Idec and Elan Announce FDA Acceptance of Supplemental ...  Nov 17, 2005
BIIB) and Elan Corporation, plc (NYSE: ELN) announced today that the supplemental Biologics License Application (sBLA) for TYSABRI(R) (natalizumab) for the ... - PharmaLive.com (press release),

Multiple sclerosis, FDA acceptance of supplemental biologics ...  Nov 19, 2005
Biogen Idec and Elan Corporation, plc announced that the supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) for the treatment of ... - Medical News Today (press release),

Study Shows Natalizumab (Tysabri) Plus interferon beta 1-a (Avonex ...  Oct 4, 2005
THESSALONIKI, GREECE -- October 4, 2005 -- The addition of natalizumab (Tysabri) to interferon beta 1-a (IFNb-1a, Avonex) over 2 years of treatment ... - DG News

News feature: Painful lessons  Oct 5, 2005
...the normal population; examples would include rhabdomyolysis with statins and progressive multifocal leukoencephalopathy with Tysabri (natalizumab; Biogen Idec ... - Nature.com (subscription),

Biogen Idec and Elan Submit Supplemental Biologics License ...  Sep 26, 2005
...(NYSE: ELN) announced today that they have submitted a supplemental Biologics License Application (sBLA) for TYSABRI ® (natalizumab) to the US Food and Drug ... - CCNMatthews (Communiqués de presse),

Biogen, Elan Again Put Fate Of Tysabri Into FDA's Hands  Sep 27, 2005
The FDA now finds itself in an unenviable position, after receiving an application to clear Tysabri (natalizumab) again, seven months after the multiple ... - BioWorld Online (subscription),

Biogen Idec and Elan Submit Supplemental Biologics License ...  Sep 26, 2005
Corporation, plc.(NYSE: ELN) announced today that they have submitted a supplementalBiologics License Application (sBLA) for TYSABRI(R) (natalizumab) tothe US ... - Finanzen.net,

Biogen Idec and Elan Submit Supplemental Biologics License ...  Sep 27, 2005
...(NYSE: ELN) announced yesterday that they have submitted a supplemental Biologics License Application (sBLA) for TYSABRI® (natalizumab) to the US Food and ... - Financial News USA (press release),

Biogen Idec cuts staff and sells assets  Sep 12, 2005
2005 - US biotechnology company Biogen Idec has succumbed to the effects of having to withdraw its multiple sclerosis drug Tysabri (natalizumab) earlier this ... - in-PharmaTechnologist,

Elan and Biogen Idec Provide an Update on TYSABRI(R)  Sep 20, 2005
NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that in the coming weeks they expect the safety evaluation of TYSABRI(R) (natalizumab) in Crohn's ... - Genetic Engineering News,

Elan/Biogen to submit supplemental license application for ms drug ...  Sep 21, 2005
Elan Corporation and US biotech firm Biogen Idec announced today that in the coming weeks they expect the safety evaluation of TYSABRI (natalizumab) in Crohn's ... - FinFacts Ireland,

World Business News Stories of Week 39, Septmeber 2005  Sep 23, 2005
Corporation and US biotech firm Biogen Idec announced this week that in the coming weeks they expect the safety evaluation of TYSABRI (natalizumab) in Crohn's ... - FinFacts Ireland,

Tysabri risk causing headache for companies  Aug 26, 2005
Interim safety results from the withdrawn multiple sclerosis treatment Tysabri (natalizumab; Biogen Idec/Elan) might have raised hopes that the drug will ... - Nature.com (subscription),

Multiple Sclerosis - TYSABRI(R) Safety Evaluation Update  Aug 15, 2005
Biogen Idec and Elan Corporation, plc announced today that findings from their safety evaluation of TYSABRI(R) (natalizumab) in patients with multiple ... - Medical News Today (press release),

No further problems in Tysabri safety review  Aug 9, 2005
PML), a rare demyelinating disease of the central nervous system, had previously been reported in patients treated with Tysabri (natalizumab), which Biogen and ... - Pharmaceutical Business Review

Tysabri Safety Data Good, But Skepticism Dies Hard  Aug 9, 2005
Scientists likely had patients in mind when they came up with Tysabri (natalizumab), the alpha-4 antagonist formerly known as Antegren, approved late last year ... - BioWorld Online (subscription),

Biogen Idec/Elan: Tysabri data tempers safety scares  Aug 10, 2005
Tysabri (natalizumab) was voluntarily withdrawn from the market in February after a patient taking a regimen of Tysabri plus Avonex (interferon beta-1a) died ... - Pharmaceutical Business Review


Other information


Indication
For treatment of multiple sclerosis

Pharmacology
In multiple sclerosis, lesions are believed to occur when activated inflammatory cells, including T-lymphocytes, cross the blood-brain barrier (BBB). Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells, and their counter-receptors present on endothelial cells of the vessel wall. The clinical effect of natalizumab in multiple sclerosis may be a secondary result of its blockade of the molecular interaction of a 4b 1-integrin expressed by inflammatory cells with VCAM-1 on vascular endothelial cells, and with CS-1 and/or osteopontin expressed by parenchymal cells in the brain.

Mechanism Of Action
binds to the α4-subunit of � 4� 1 and � 4� 7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the � 4-mediated adhesion of leukocytes to their counter-receptor(s).

Drug Category
Immunomodulatory Agents

Brand Names/Synonyms
Tysabri; anti-VLA4; anti-alpha4 integrin ; Tysabri (Antegren)

Dosage Forms
Not Available

Absorption
Not Available

Interactions
Not Available

Chemical IUPAC Name
Humanized anti a4 integrin antibody

Chemical Formula
Not Available

Half Life
Not Available

Drug Type
Approved Drug

# Accession No
BIOD00083

CAS Registry Number
Not Available

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