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Topic: Tysabri

	Questions and Answers on Natalizumab (marketed as Tysabri)
		Tysabri is a monoclonal antibody that binds to a protein called alpha-4-integrin.
		Tysabri is approved to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations.
		Tysabri was approved on the basis of a clinical study showing that Tysabri, when added to Avonex, reduced the risk of exacerbations by 54% compared to Avonex alone.
	www.fda.gov /cder/drug/infopage/natalizumab/natalizumabQA_2_2005.htm (1645 words)

	Tysabri® Formerly known as Antegren (Site not responding. Last check: 2007-10-10)
		Tysabri® is a type of medication called a “monoclonal antibody” Tysabri® works by blocking certain types of white blood cells from entering the central nervous system (brain and spinal cord).
		In a Phase 3 trial of Tysabri® compared to placebo, at one year, Tysabri® was shown to reduce the annual relapse rate by 66% and new (gadolinium enhanced) MRI lesions by 92% when comparing the Tysabri® group to the placebo group of patients.
		Tysabri® infusions are indicated for individuals with relapsing MS who are having clinical activity and/or MRI activity.
	www.umm.edu /ms/tysabri.html (1087 words)

	TYSABRI gets accelerated FDA approval for Multiple Sclerosis - The Doctors Lounge(TM)
		TYSABRI is the first humanized monoclonal antibody approved for the treatment of multiple sclerosis (MS).
		TYSABRI, the first humanized monoclonal antibody approved for the treatment of MS, inhibits adhesion molecules on the surface of immune cells.
		TYSABRI reduced the rate of clinical relapses by 66 percent relative to placebo (p<0.001), the primary endpoint at one-year.
	www.thedoctorslounge.net /neurology/articles/tysabri_approval (1306 words)

	Multiple Sclerosis Society Website - Welcome to the MS Society - Tysabri
		Tysabri was approved by the FDA on November 24 2004, for use in people with relapsing forms of MS.
		Tysabri and Avonex in combination were shown to reduce relape rates by over 50% compared to Avonex alone.
		Tysabri is given once a month as an intravenous infusion (into a vein) over a one-hour period in a hospital or clinic setting.
	www.mssociety.org.uk /research/research_explained/tysabri.html (471 words)

	Breaking News: TYSABRI (Photo: Business Wire)
		TYSABRI will be available upon the completion of key activities related to the risk management plan, including FDA review of educational and training materials, internal validation of systems based on final FDA requirements and training of internal personnel.
		TYSABRI increases the risk of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability.
		TYSABRI is contraindicated in patients who have or have had PML or with known hypersensitivity to TYSABRI or any of its components.
	www.genengnews.com /news/bnitem.aspx?name=2208355 (1281 words)

	Tysabri Data Lift Biogen Idec, Elan (Site not responding. Last check: 2007-10-10)
		The Food and Drug Administration granted accelerated approval for Tysabri in the treatment of MS in November 2004, based on one-year results from the Affirm trial as well as those of an add-on study known as Sentinel.
		In the Sentinel trial of a combined treatment with Tysabri and Avonex, a drug currently on the market, clinical relapses were reduced by 54% compared with the use of Avonex alone.
		Tysabri has been associated with hypersensitivity reactions, including serious systemic reactions, which occurred at an incidence of less than 1% of patients.
	www.thestreet.com /_googlen/stocks/biotech/10217281.html?cm_ven=GOOGLEN&cm_cat=FREE&cm_ite=NA (529 words)

	Bloomberg.com: U.K. (Site not responding. Last check: 2007-10-10)
		She based her prediction on a survey of 140 neurologists that found 57 percent said Tysabri's effectiveness is worth the risk of developing the brain infection only for patients who failed other MS therapies.
		Tysabri, given as a once-a-month intravenous infusion, was the most expensive multiple-sclerosis therapy on the market, costing about $23,000 a year.
		Tysabri, an antibody-based medicine, was designed to prevent that assault by suppressing immune cells.
	www.bloomberg.com /apps/news?pid=10000102&sid=aLhFHBQ3ZO_Q&refer=uk (1178 words)

	Tysabri brain damage, injury - St. Louis Lawyers, Multiple Sclerosis Drug, Dangerous Prescription Drugs
		Tysabri is the first humanized monoclonal antibody approved for the treatment of MS.
		Tysabri, which Biogen had marketed in conjunction with Ireland's Elan Pharmaceuticals, had been heralded as a new hope for multiple sclerosis patients.
		More information from the FDA on the Tysabri suspension can be found at: public health advisory and questions and answers: www.fda.gov/cder/drug/infopage/natalizumab.
	www.brownandcrouppen.com /tysabri.html (637 words)

	Bloomberg.com: U.S.
		Tysabri sales may reach as much as $1.25 billion a year if used for the wider group of patients the panel recommended, instead of about $300 million if use of the drug were to be more restricted, she said.
		Tysabri had been seen as the best hope in a decade for the world's 2.5 million MS patients, with potential annual sales of $3 billion.
		Tysabri's prescribing information should include the FDA's strictest warning, outlined in a fl box, that the drug is associated with an increased risk of PML, Biogen said yesterday.
	www.bloomberg.com /apps/news?pid=10000103&sid=azHeaG.8AscA (1294 words)

	The latest news on the multiple sclerosis medication Tysabri and PML (Site not responding. Last check: 2007-10-10)
		Tysabri was withdrawn after being linked to progressive multifocal leukoencephalopathy, a rare neurological disease, in two patients, both of whom were taking a combination of the two drugs.
		Tysabri, which is designed to suppress the symptoms of multiple sclerosis and Crohn’s disease, has had a rocky road to say the least.
		Tysabri, once expected to be a powerful new mainstay in the treatment of multiple sclerosis, has been linked to a third case of a rare and deadly brain infection, according to the drug's makers, Elan and Biogen Idec.
	www.weitzlux.com /tysabrimultiplesclerosismedicationpml_605.html (796 words)

	Tysabri Information from Drugs.com
		Tysabri is an monoclonal antibody that affects the actions of the body's immune system.
		Tysabri is in the FDA pregnancy category C. This means that it is not known whether Tysabri will be harmful to an unborn baby.
		Tysabri should only be administered under the supervision of a qualified healthcare provider.
	www.drugs.com /tysabri.html (1045 words)

	SignOnSanDiego.com > News > Business -- Second fatality staggers Tysabri
		Unlike the two MS patients identified in February, who took Tysabri in combination with an older Biogen Idec MS drug, Avonex, the third case involves a patient who suffered from Crohn's disease and was taking Tysabri alone as part of a different set of Crohn's clinical trials.
		Tysabri had been expected to generate sales of more than $1 billion a year, driving growth for both companies.
		Biogen Idec and Elan said their evaluation of Tysabri's safety, which includes a reassessmant of the 3,000 clinical trial patients, is continuing and could take months.
	www.signonsandiego.com /news/business/20050331-9999-1b31biogen.html (659 words)

	Tysabri Is No Blockbuster - Forbes.com (Site not responding. Last check: 2007-10-10)
		In all, they say, there have been three confirmed cases of PML in Tysabri patients, two of them in subjects with multiple sclerosis and one in a subject with Crohn's disease.
		Tysabri is linked to the PML cases, but the MS patients were also taking Avonex, another Biogen drug.
		On a conference call with analysts at Sanford C. Bernstein last week, Daniel Wynn, a multiple sclerosis investigator, said that most patients being evaluated for safety were not given spinal taps--the most conclusive test for PML and the virus that causes it.
	www.forbes.com /business/2005/08/09/drugs-biogen-tysabri-cx_mh_0809tysabri2.html (802 words)

	This Is MS \| Unbiased Multiple Sclerosis Research, News, and Community (Site not responding. Last check: 2007-10-10)
		The reapproval of Tysabri effectively brings to a close a long and drawn out battle fought not only in laboratories and board rooms, but as is so often ignored, in the hearts and psyches of people affected by MS looking for a better alternative to treating their condition.
		Tysabri's saga is a long and convoluted tale, full of both hope and heartbreak-- much like the relapsing-remitting nature of the disease type which it is intended to treat.
		In short, Tysabri continued to demonstrate strong efficacy in terms of disability progression and relapses, a relatively low side effect profile, and (hold your breath)-- a risk of PML that has been preliminarily quantified as approximately 1 in 1000, when a person is given nearly 18 months of exposure to Tysabri.
	www.thisisms.com /modules.php?name=News&new_topic=56 (4271 words)

	Tysabri and Multiple Sclerosis (MS) -- WebMD
		On June 5, 2006, the FDA allowed the drug Tysabri back on the market after there were no additional cases of PML in a clinical trial that was resumed in February 2006 and on re-examination of patients from the previous clinical trials.
		Tysabri is unique among MS drugs in that it works by blocking the effects of white blood cells, which are believed to be harmful to the nervous system (brain, spinal cord, and nerves) and may create the damaging effects of MS.
		Tysabri is given intravenously (through a vein) over the course of an hour every four weeks in a doctor's office.
	www.webmd.com /content/pages/20/105419.htm (359 words)

	This Is MS Forums - Is Tysabri available in Canada? \| Unbiased Multiple Sclerosis Research, News, and Community
		Tysabri has not been approved by Health Canada as yet and per my conversation with a MS Neurologist in December, it likely won't be until sometime later this year.
		Tysabri, on the first year evidence, appeared to show that it was more effective than the CRAB drugs and avoided the need for daily / weekly injections.
		Tysabri is currently not available for sale in Canada, but O'Leary is so convinced of its usefulness that she had been paying up to $4,000 for flight, hotel and the monthly drug treatment at a clinic in Cleveland.
	www.thisisms.com /modules.php?name=Forums&file=viewtopic&t=868 (3296 words)

	The Tysabri Game Plan - Forbes.com (Site not responding. Last check: 2007-10-10)
		Tysabri was pulled from the market by the companies in February 2005 after three patients being treated with Tysabri and Avonex developed progressive multifocal leukoencephalopathy, or PML.
		Her firm's recent survey of 140 neurologists revealed that doctors continue to be wary of safety risks: More than three-quarters of the neurologists polled said they would prescribe the drug--but to just 10% of their patients.
		In addition, Tysabri use could be limited to a subgroup of MS patients called "relapsing remitting," one of four main variations of the disease.
	www.forbes.com /business/2006/03/08/tysabri-elan-biogen-cx_pk_0308tysabri.html?partner=rss (1027 words)

	Tysabri Lawyers, Tysabri Claims Attorneys
		Tysabri won accelerated approval from the FDA in November 2004, as an innovative treatment for multiple sclerosis (MS).
		Tysabri works by suppressing the immune system to slow the progression of MS, which strips the lining from the body’s nerves.
		However, Tysabri may have caused a severe side effect, with a rare brain disorder – progressive multifocal leukoencephalopathy (PML), for which there is no known effective treatment – stripping the lining from the nerves in patients’ brains much more rapidly than would have occurred with MS.
	www.klinespecter.com /tysabri.html (787 words)

	Tysabri Progressive Multifocal Leukoencephalopathy (PML) Side Effects Attorney
		The Food and Drug Administration (FDA) approved Tysabri, which was called Antegren during clinical trials, in an accelerated process after a late-stage study showed that it reduced MS relapses by 66 percent compared with a placebo.
		When sales of Tysabri were suspended on February 28, 2005, many critics of the highly controversial MS drug, with potentially fatal side-effects, hoped that would end the saga of a medication that many experts believed should never have been approved in the first place.
		Tysabri, the multiple sclerosis drug from Biogen Idec (BIIB:Nasdaq) and Elan (ELN:NYSE ADR), should return to the market but with strict limitations because of safety concerns, according to a survey of doctors conducted by investment research firm Piper Jaffray.The survey revealed that while 92%...
	www.yourlawyer.com /topics/overview/tysabri (950 words)

	National MS Society \| Research Bulletin (Site not responding. Last check: 2007-10-10)
		The fate of Tysabri for MS will depend on the investigation of the adverse events that occurred, and a thorough evaluation of the data available from all treated patients involved in the clinical trials of Tysabri.
		It is possible that Tysabri will be removed permanently from the market, and it is also possible that Tysabri will be returned to the market.
		In order to protect the privacy of the patients involved, any reports to the public will be very general in nature, such as the number of patients diagnosed with PML and their clinical outcomes.
	www.nationalmssociety.org /Research-2005Feb28.asp (1975 words)

	Tysabri (natalizumab) marketing suspension information on MedicineNet.com
		FDA has received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed, fatal case and one additional case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for multiple sclerosis (MS).
		To further understand the association between Tysabri and the development of PML, Biogen Idec is reviewing all adverse events in the clinical trial database for Tysabri to determine if any of these could possibly represent cases of PML.
		Tysabri when added to Avonex reduced the risk of exacerbations by 54% compared to Avonex alone.
	www.medicinenet.com /script/main/art.asp?articlekey=47298 (772 words)

	CCFA.org: Tysabri Update Safety
		Tysabri also was under study as a potential treatment for Crohn's disease and rheumatoid arthritis.
		In its most recent public health advisory, the FDA stated that although the relationship between Tysabri and PML is not yet known, all clinical testing of the drug has been suspended.
		The FDA has urged patients formerly treated with Tysabri or enrolled in clinical trials of the drug to consult their physician to explore alternative treatments.
	www.ccfa.org /about/news/tysabriupdate2 (261 words)

	Multiple Sclerosis Foundation Forum - Tysabri costs (Site not responding. Last check: 2007-10-10)
		My main concern with Tysabri is that the entire trial protocol was pushed up by a year and the normal evaluation process hasn't been done.
		And his comments....trials aren't finished yet, too soon to know just how good it may be, we in the research field don't really trust Biogen all that much when it comes to their data, it hasn't shown any positive effect on the EDSS scale for MS patients so far.
		Your talking about the drug trials for tysabri is the height of irony when your wife CHOOSES prokarin and that's hardly undergone any testing, but I think it's just fine for her; if it's what SHE wants.
	www.msfacts.org /dcforum/DCForumID2/4957.html (5266 words)

	Q&A: Biogen's Multiple Sclerosis Drug Tysabri (Site not responding. Last check: 2007-10-10)
		Tysabri - a multiple sclerosis drug by Biogen Idec Inc. and Elan Corp, will likely make a comeback to the market, as a U.S. Food and Drug Administration advisory committee voted unanimously (12 to 0) Wednesday to recommend its comeback.
		Therefore, if a study is done in a manner that provides as much safety monitoring as feasible, it is reasonable to resume studying this product under IND to obtain more safety-related information that may permit us to begin to better understand how large or small the true risks associated with natalizumab are.
		The manufacturer is reviewing the records of all patients who have received Tysabri in a clinical trial and evaluating these patients to determine if there any other cases of PML in this population.
	www.foodconsumer.org /777/8/Q_A_Biogen_s_Tysabri.shtml (3073 words)

	Newly Approved Drug Therapies (869): TYSABRI (natalizumab), Elan Pharmaceuticals / Biogen Idec
		TYSABRI (natalizumab) is a recombinant humanized IgG4k monoclonal antibody produced in murine myeloma cells.
		In development, TYSABRI was originally slated to be named Antegren, but FDA regulators forced a change due to name confusion with existing products such as Integrilin and Edecrin.
		TYSABRI is indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations.
	www.centerwatch.com /patient/drugs/dru869.html (810 words)

	Multiple Scleroris - Tysabri® Plus Avonex® Giving Good Results
		When TYSABRI was added to Copaxone, there was no increase in the rate of new active MRI lesion formation, a safety measure and the primary endpoint of the study.
		Biogen Idec and Elan are collaborating equally on the development of TYSABRI in MS, Crohn's disease, and rheumatoid arthritis.
		Information about TYSABRI, including the voluntary suspension of marketing, U.S. prescribing information and support services, is available through a single toll-free number (1-800-456-2255), and via http://www.TYSABRI.com.
	www.medicalnewstoday.com /medicalnews.php?newsid=22953 (1282 words)

	Tysabri® Two-Year Phase III Multiple Sclerosis Clinical Trial Results And Safety Evaluation Published In NEJM (Site not responding. Last check: 2007-10-10)
		Two-year AFFIRM Phase III monotherapy data published today showed that treatment with TYSABRI reduced the risk of disability progression by 42% (p>0.001), the primary endpoint of the study, and led to a 68% reduction (p>0.001) in the annualized relapse rate compared to placebo.
		Both AFFIRM and SENTINEL were designed to evaluate the effect of TYSABRI on the progression of disability as measured by at least a one-point worsening on the Expanded Disability Status Scale (EDSS) sustained for three months, and on the rate of clinical relapses.
		The commercial potential and regulatory path forward of TYSABRI are subject to a number of risks and uncertainties.
	www.medicalnewstoday.com /medicalnews.php?newsid=38881 (1043 words)

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