Tysabri PML Cases Get Attention of European Drug AgencyAug 14, 2008 | Parker Waichman LLP
European health regulators are taking a hard look at two cases of a potentially lethal brain infection linked to the drug Tysabri. About 31,800 people take Tysabri, which is also used to treat Multiple Sclerosis and Crohn’s disease, a digestive condition. Earlier this month, Elan and Biogen Idec, the makers of the drug, revealed that three European Tysabri patients had been diagnosed with progressive multifocal leukoencephalopathy, or PML.
PML attacks the brain and central nervous system and is usually fatal. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled. In 2006, Tysabri was temporarily removed from the US market after it was learned that some patients died of PML during its clinical trials. But it was returned to the market a year later.
According to Biogen Idec and Elan, one of the European PML patients is ambulatory and the other is hospitalized. One patient had been taking Tysabri for 14 months and the other for 17. The most disturbing aspect of these latest PML cases, however, is that both patients had been taking Tysabri as monotherapy - with no other drugs. It had been theorized that patients contracting PML had done so because of exposure to multiple medications and that monotherapy with Tysabri was less risky.
On Wednesday, the European Medicines Agency said it was assessing the two cases of PML. The agency said it would then decide whether any changes were necessary to the currently approved label for product.
In 2005, the law firm Parker Waichman LLP was retained by the estate of Anita Smith, a patient who died from a confirmed case of PML after taking Tysabri during a clinical trial. In its 2005 Annual Report, Elan Inc. informed shareholders that it had entered into settlement talks with the lawyers representing Anita Smith’s estate. When contacted, Jerry Parker, the managing partner of Parker Waichman LLP said the Anita Smith Tysabri case had been resolved, but that the case was confidential.