Tysabri Label Modified to Include More Brain Infection Data

<"http://www.yourlawyer.com/topics/overview/tysabri">Tysabri, the multiple sclerosis drug marketed by Biogen Idec Inc. and Elan Corp is having its label updated to include new data about the incidence of progressive multifocal leukoencephalopathy, or PML, a rare brain infection. According to a report from The Wall Street Journal, the U.S. Food & Drug Administration (FDA) will be posting a “Drug Safety Communication” on the label changes in the coming days.

The new Tysabri label information includes a table that details the incidence of PML. It also includes information on a newly identified PML risk factor of patients taking certain immune-system suppressing medication prior to taking Tysabri, the Journal said.

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.

The data in the newly-added table – current as of January – shows the risk of getting the infection is 0.3 patients per 1,000 when using the drug for less than two years, the Journal said. That rate rises when using the drug for two to three years, to 1.5 cases, but drops to 0.9 cases for the period of three to four years.

As we’ve reported in the past, Biogen Idec and Elan provide monthly updates on the number of PML cases associated with Tysabri. As of early March, 102 cases of the infection were confirmed in Tysabri patients, including 21 deaths, according to the Journal.

Though considered one of the most effective multiple sclerosis treatments available, Tysabri is generally only used in people who have not responded to other treatments. It was actually removed from the market in 2005 because of its association with PML, after three patients in a Tysabri clinical trial developed the disease.

One of those patients was Anita Smith, who died from a confirmed case of PML on February 24, 2005. In November 2004, while her health was rapidly deteriorating, Tysabri gained a coveted “fast-track” approval FDA. Despite her PML symptoms, Smith was allowed to continue receiving treatment in the Tysabri trial, and took her last IV infusion of the drug in January 2005. Four days after Smith’s death, Tysabri sales were halted.

In its 2005 Annual Report, Elan Inc. informed shareholders that it had entered into settlement talks with the lawyers representing Anita Smith’s estate. <"http://www.yourlawyer.com/">Parker Waichman Alonso LLP, the law firm representing the estate, said the Anita Smith Tysabri case had been resolved, but information on the resolution was confidential.

Tysabri was reapproved in 2006, but is now subject to restrictions due to its association with PML.

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