Woman sues over PML
An American woman who developed the brain infection PML after treatment with natalizumab (Tysabri) is suing the manufacturers, Biogen and Elan, for not warning her about the risks.
Boston Globe
PML (Progressive multifocal leukoencephalopathy) - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - September 9, 2013 Category: Neurology Source Type: news
FDA Investigating a Case of PML With GilenyaFDA Investigating a Case of PML With Gilenya
A safety announcement from the FDA today outlines a case of PML in a patient taking fingolimod not previously treated with natalizumab. News Alerts (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - August 29, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news
FDA Warns of PML Case With Gilenya
(MedPage Today) -- SILVER SPRING, Md. -- A patient being treated for multiple sclerosis and who had no history of using natalizumab (Tysabri) developed progressive multifocal leukoencephalopathy (PML) while taking fingolimod (Gilenya), the FDA said. (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - August 29, 2013 Category: American Health Source Type: news
Progressive Multifocal Leukoencephalopathy in MSProgressive Multifocal Leukoencephalopathy in MS
While natalizumab-associated progressive multifocal leukoencephalopathy remains a rare occurrence, it is still a serious cause for concern. How can the risk be assessed and mitigated? Current Opinion in Neurology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 26, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery Journal Article Source Type: news
JCV Test Stratifies PML Risk in Antibody-Positive MSJCV Test Stratifies PML Risk in Antibody-Positive MS
A quantitative test for antibodies to JC virus stratifies antibody-positive patients with MS for the risk of contracting PML if they receive natalizumab, possibly allowing some with low antibody levels to continue the drug. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 14, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
Tysabri and PML risk
Information on further refining the stratification of risk of PML in people taking natalizumab (Tysabri) - particularly in people who are antibody positive - was presented at the recent European Neurology Society meeting.
Medscape (requires free resistration)
PML (Progressive multifocal leukoencephalopathy) - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - June 13, 2013 Category: Neurology Source Type: news
JCV Test 'Useful But Not Sufficient' to Gauge PML RiskJCV Test 'Useful But Not Sufficient' to Gauge PML Risk
In correspondence in the New England Journal of Medicine, researchers report that patients with MS taking natalizumab who are negative for antibodies to JC virus can nonetheless have JC viral DNA present. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - June 6, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
Tysabri Screening Test May Be Unreliable (CME/CE)
(MedPage Today) -- About one-third of multiple sclerosis patients testing negative for antibodies against the JC virus -- suggesting that natalizumab (Tysabri) would be relatively safe -- were found to have active viremia. (Source: MedPage Today Neurology)
Source: MedPage Today Neurology - June 5, 2013 Category: Neurology Source Type: news
Tysabri screening concerns
A paper in the New England Journal of Medicine questions the accuracy of the test for the JC virus in people taking Tysabri. From a small sample, researchers identified 17 people who had been exposed to the virus when checking for both JCV antibodies and DNA. Six of these had shown as free of the virus when checked for JCV antibodies alone (the standard test).
MedPage Today
Natalizumab (Tysabri) - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - June 4, 2013 Category: Neurology Source Type: news
Natalizumab (Tysabri) licence extension withdrawn
The manufacturers of natalizumab (Tysabri) have withdrawn their application to extend the European licence to include any people with relapsing remitting MS who didn't have JC virus antibodies. The drug is currently only licensed for people with highly active disease. The evidence available was not yet strong enough to achieve the extension.
EMA
Natalizumab (Tysabri) - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - May 30, 2013 Category: Neurology Source Type: news
Royalty Pharma increases takeover bid for Elan
Royalty Pharma has increased its offer to buy Irish pharmaceutical business Elan to $12 per share, an offer that values the developer of multiple sclerosis drug Tysabri at $7.3bn. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - April 15, 2013 Category: Pharmaceuticals Source Type: news
Exclusive: Royalty Pharma considers sweetened deal for Elan - sources
NEW YORK (Reuters) - Investment firm Royalty Pharma is considering sweetening its $6.6 billion offer for Irish drugmaker Elan by paying Elan shareholders more if the multiple sclerosis drug Tysabri hits certain sales milestones, two people familiar with the matter said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - April 11, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
Low Body Weight Linked to PML Risk With Natalizumab in MS Low Body Weight Linked to PML Risk With Natalizumab in MS
Results of a new study suggest that low body mass may be a risk factor for progressive multifocal leukoencephalopathy in natalizumab-treated patients with multiple sclerosis. Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - April 3, 2013 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news
PML and body weight
Analysis presented at last month's AAN (American Academy of Neurology) meeting found that PML (progressive multifocal leukoencephalopathy), a side effect of Tysabri, was more prevalent in people with lower body weight. Whether weight is the risk factor or just indicative of something else is not clear.
Medscape (requires free registration)
PML (Progressive multifocal leukoencephalopathy) - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - April 2, 2013 Category: Neurology Source Type: news
MS brain bank
The role of the MS brain bank at Imperial College in the development of Tysabri and other potential treatments for MS.
Imperial College
Organ donations - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - March 19, 2013 Category: Neurology Source Type: news
