September 14, '09: TWO new PML cases found in MS Patients
Category: Tysabri Related
Posted by: stuart
TWO MORE Brain-infection cases have emerged
Two more cases of a rare brain infection have emerged in users of the multiple-sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, the first such incidences since Biogen stopped updating investors of the situation in July.
At that time, Biogen had confirmed 11 cases of progressive multifocal leukoencephalopathy, or PML, since the drug's relaunch in July 2006; Tysabri was pulled from the U.S. market in 2005 because of PML concerns.
A Biogen spokeswoman said the Cambridge, Mass., biotech company is neither commenting on nor confirming the existence of additional cases as long as the PML rate is consistent with the rate of one-in-1,000 patients implied by the label. The new cases appear to be in line with the label's rate.
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posted by: Stuart Schlossman - RRMS
April 20, '09: Biogen's Tysabri Reports 6th Case of PML
Category: Tysabri Related
Posted by: stuart
Yahoo News
Monday April 20, 2009
This past weekend, Biogen Idec, Inc. (NasdaqGS: BIIB - News) reported that another patient taking Tysabri had developed a case of progressive multifocal leukoencephalopathy, or PML.
This is the sixth case of PML since July 2008. In the most recent case, a patient being treated for multiple sclerosis on Tysabri developed the disease after 31 months. All patients are taking Tysabri as a monotherapy, with the minimum therapy before noted disease of 12 months. The average length of time for the sixth patients dosing is 19 months. Five of the six reported cases were located outside the U.S.
Despite the new case of PML, Biogen Idec and Elan continue to educate and train physicians under the risk management plan (RiskMAP). This includes the recent warning on potential liver damage as well. As of the end of the first quarter, there are currently 39,900 patients on Tysabri worldwide (20,800 in the U.S, 18,500 Ex-U.S, 600 in clinical trials).
=============================================Monday April 20, 2009
This past weekend, Biogen Idec, Inc. (NasdaqGS: BIIB - News) reported that another patient taking Tysabri had developed a case of progressive multifocal leukoencephalopathy, or PML.
This is the sixth case of PML since July 2008. In the most recent case, a patient being treated for multiple sclerosis on Tysabri developed the disease after 31 months. All patients are taking Tysabri as a monotherapy, with the minimum therapy before noted disease of 12 months. The average length of time for the sixth patients dosing is 19 months. Five of the six reported cases were located outside the U.S.
Despite the new case of PML, Biogen Idec and Elan continue to educate and train physicians under the risk management plan (RiskMAP). This includes the recent warning on potential liver damage as well. As of the end of the first quarter, there are currently 39,900 patients on Tysabri worldwide (20,800 in the U.S, 18,500 Ex-U.S, 600 in clinical trials).
March 24, '09: Biogen Tests Malaria Drug for Tysabri Brain Infection (PML)
Category: Tysabri Related
Posted by: stuart
March 24 (Bloomberg) -- Biogen Idec Inc. may have found a treatment for the deadly brain infections that have been tied to use of its multiple sclerosis drug Tysabri, the biotechnology company’s fastest-growing product.
A malaria pill developed during the Vietnam War is being tested by Biogen on patients with progressive multifocal leukoencephalopathy, the brain disorder known as PML, said Al Sandrock, Biogen’s head of neurology research. Tysabri was pulled from the market in 2005 after three PML cases were reported. It was reintroduced a year later when U.S. regulators said the medication’s effectiveness, twice that of other MS drugs, outweighed its risks.
=============================================A malaria pill developed during the Vietnam War is being tested by Biogen on patients with progressive multifocal leukoencephalopathy, the brain disorder known as PML, said Al Sandrock, Biogen’s head of neurology research. Tysabri was pulled from the market in 2005 after three PML cases were reported. It was reintroduced a year later when U.S. regulators said the medication’s effectiveness, twice that of other MS drugs, outweighed its risks.
December 23, '08: Only one in 10 people with multiple sclerosis are being treated with key drug, (UK) government admits
Category: Tysabri Related
Posted by: stuart
Guardian.co.uk - Tuesday 16 December 2008
Sarah Boseley, health editor
Only around one in 10 of those who are eligible for a new drug to treat multiple sclerosis are getting it, even though it was approved a year ago for use in the NHS, the Guardian has been told.
Natalizumab, which goes by the brand name Tysabri, is the first drug that the National Institute for Clinical Excellence has approved for multiple sclerosis.
=============================================Sarah Boseley, health editor
Only around one in 10 of those who are eligible for a new drug to treat multiple sclerosis are getting it, even though it was approved a year ago for use in the NHS, the Guardian has been told.
Natalizumab, which goes by the brand name Tysabri, is the first drug that the National Institute for Clinical Excellence has approved for multiple sclerosis.
December 19, '08: Multiple Sclerosis Patient who was using Tysabri developed PML (a Brain illness) and has died
Category: Tysabri Related
Posted by: stuart
Bloomberg
Biogen Says Tysabri Patient With Brain Illness Died
By Elizabeth Lopatto
Dec. 19 (Bloomberg) -- A multiple sclerosis patient who developed a severe brain infection after taking Biogen Idec Inc. and Elan Corp.’s Tysabri, the fourth case reported in five months, has died, according to Biogen.
Cambridge, Massachusetts-based Biogen was informed of the American woman’s death two days ago, company spokeswoman Naomi Aoki said in an interview.
The company reported on Oct. 29 that the patient had been diagnosed with the brain illness, progressive multifocal leukoencephalopathy (PML).
=============================================Biogen Says Tysabri Patient With Brain Illness Died
By Elizabeth Lopatto
Dec. 19 (Bloomberg) -- A multiple sclerosis patient who developed a severe brain infection after taking Biogen Idec Inc. and Elan Corp.’s Tysabri, the fourth case reported in five months, has died, according to Biogen.
Cambridge, Massachusetts-based Biogen was informed of the American woman’s death two days ago, company spokeswoman Naomi Aoki said in an interview.
The company reported on Oct. 29 that the patient had been diagnosed with the brain illness, progressive multifocal leukoencephalopathy (PML).
December 09, '08: Natalizumab Use in Pediatric Multiple Sclerosis
Category: Tysabri Related
Posted by: stuart
Vol. 65 No. 12, December 2008
Archives of Neurology
Peter Huppke, MD; Wiebke Stark, MD; Claudia Zürcher, MD; Brenda Huppke, MD; Wolfgang Brück, MD; Jutta Gärtner, MD
Arch Neurol. 2008;65(12):1655-1658.
Background: Natalizumab, a humanized monoclonal antibody raised against 4 integrins, is approved for treatment of active relapsing-remitting multiple sclerosis (RRMS) in adult patients.
Objective: To determine the safety, effectiveness, and tolerability of natalizumab use in pediatric patients with MS.
Design: Case report.
=============================================Archives of Neurology
Peter Huppke, MD; Wiebke Stark, MD; Claudia Zürcher, MD; Brenda Huppke, MD; Wolfgang Brück, MD; Jutta Gärtner, MD
Arch Neurol. 2008;65(12):1655-1658.
Background: Natalizumab, a humanized monoclonal antibody raised against 4 integrins, is approved for treatment of active relapsing-remitting multiple sclerosis (RRMS) in adult patients.
Objective: To determine the safety, effectiveness, and tolerability of natalizumab use in pediatric patients with MS.
Design: Case report.
September 22, '08: TYSABRI® Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis Patients
Category: Tysabri Related
Posted by: stuart
19 September 2008
TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in Disability Progression and Sustained Improvement in Physical Disability
MONTREAL--(BUSINESS WIRE)--Sept. 19, 2008--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial and were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.
=============================================
TYSABRI® Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis Patients According to New Post-Hoc Analysis
TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in Disability Progression and Sustained Improvement in Physical Disability
MONTREAL--(BUSINESS WIRE)--Sept. 19, 2008--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial and were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.
Category: Tysabri Related
Posted by: stuart
Tysabri PML Cases in Europe Prompt FDA to Seek Labeling Change
Date Published: Monday, August 25th, 2008
NewsInferno.com
Federal regulators informed healthcare providers today that monotherapy with Tysabri has been linked to two new European cases of progressive multifocal leukoencephalopathy (PML). The U.S. Food & Drug Administration (FDA) said it is working with Elan and Biogen Idec, the manufacturers of Tysabri, to amend the product labeling to inform prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy.
In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the dug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.
=============================================Date Published: Monday, August 25th, 2008
NewsInferno.com
Federal regulators informed healthcare providers today that monotherapy with Tysabri has been linked to two new European cases of progressive multifocal leukoencephalopathy (PML). The U.S. Food & Drug Administration (FDA) said it is working with Elan and Biogen Idec, the manufacturers of Tysabri, to amend the product labeling to inform prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy.
In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the dug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.
August 19, '08: Tysabri Forecast to Achieve Blockbuster Status by 2014
Category: Tysabri Related
Posted by: stuart
Pharmiweb
AVOS Life Sciences
Posted on:19 Aug 08
MORRISVILLE, N.C. (Aug. 18, 2008) - AVOS Life Sciences contends that Tysabri will exceed $1 billion in sales by 2014 as previously forecasted in the AVOS Therapeutic Market Outlook (TMO) Multiple Sclerosis Report released on July 1, 2008. In addition, the market dynamics featured in the report remain the same despite the recent cases of progressive multifocal leukoencephalopathy (PML) associated with Tysabri.
=============================================AVOS Life Sciences
Posted on:19 Aug 08
MORRISVILLE, N.C. (Aug. 18, 2008) - AVOS Life Sciences contends that Tysabri will exceed $1 billion in sales by 2014 as previously forecasted in the AVOS Therapeutic Market Outlook (TMO) Multiple Sclerosis Report released on July 1, 2008. In addition, the market dynamics featured in the report remain the same despite the recent cases of progressive multifocal leukoencephalopathy (PML) associated with Tysabri.
August 04, '08: Tysabri has a "Voice" - this from a Tysabri user
Category: Tysabri Related
Posted by: stuart
Tysabri speaks thru the description of a well-informed MS patient who vows to live-on and live well, but only thru the need and use of her Tysabri Infusions:
Date: Sunday- August 3, 2008
Published by Stuart Schlossman of MS Views and Related News.com
Lauren of California wrote the following:
Hi Stuart,
Time for everyone to calm down and take a deep breath... Damage Control..., I have been receiving e-mails left and right from MS patients currently on Tysabri therapy about the two new cases of PML which were just reported by Biogen/Élan. This news of the two new cases of PML have already hit the
MS boards/forums... I'm trying to keep everyone calm until all relevant facts have been disclosed by the companies...
=============================================
Date: Sunday- August 3, 2008
Published by Stuart Schlossman of MS Views and Related News.com
Lauren of California wrote the following:
Hi Stuart,
Time for everyone to calm down and take a deep breath... Damage Control..., I have been receiving e-mails left and right from MS patients currently on Tysabri therapy about the two new cases of PML which were just reported by Biogen/Élan. This news of the two new cases of PML have already hit the
MS boards/forums... I'm trying to keep everyone calm until all relevant facts have been disclosed by the companies...
