Biogen Idec. Inc. recently reported the 13th confirmed case of progressive multifocal leukoencephalopathy (PML) in a patient taking the company’s drug Tysabri. PML is a rare and often fatal viral disease that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations.

According to reports, the patient with the latest confirmed PML case took 35 doses of the monthly medication, the most of any of the post-launch cases, and was located overseas. Only two of the nine cases since last July were located in the U.S.

In 2005, a link between Tysabri and PML led to the drug being pulled off the market for 18 months (read the story here).The drug was relaunched in 2006 due to its effectiveness in fighting MS.

According to The Wall Street Journal the drug missed Biogen’s projection for quarterly sales of $250 million last year — sales of the drug were $227 million from January to March — and Biogen has stepped back from a goal of reaching 100,000 patients by the end of next year.

It is reported, however, that the long-projected risk of developing the PML infection while on Tysabri is well below 1 in 1,000 patients.

Important information you should know about TYSABRI from www.tysabri.com.
TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). PML usually happens in people with weakened immune systems.

No one can predict who will get PML

There is no known treatment, prevention, or cure for PML

Your chance of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other MS treatments.

Even if you use TYSABRI alone to treat your MS, it is not known if your chance of getting PML will be lower. It is also not known if treatment for a long period of time with TYSABRI can increase your chance of getting PML.

TYSABRI is available only through a restricted distribution program called the TOUCH™ Prescribing Program. In order to receive TYSABRI, you must talk to your doctor and understand the benefits and risks of TYSABRI and agree to all of the instructions in the TOUCH Prescribing Program.

If you take TYSABRI, it is important that you call your doctor right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days. Tell all of your doctors that you are getting treatment with TYSABRI.

TYSABRI is a prescription medicine approved for patients with relapsing forms of MS to:

— Slow the worsening of disability that is common in patients with MS

— Decrease the number of flare-ups (relapses)

Because of the chance of getting PML, TYSABRI is generally recommended for patients that have not been helped enough by, or cannot tolerate other treatments for MS.
TYSABRI does not cure MS.

TYSABRI has not been studied for use longer than 2 years. Also, TYSABRI has not been studied in patients with chronic progressive MS, or in children.

It is not known if patients older than 65 years have a different response to TYSABRI.

For more information, please visit www.tysabri.com or www.biogenidec.com.

This entry was posted on Monday, June 15th, 2009 at 11:24 am and is filed under All Articles, News Alerts. You can follow any responses to this entry through the RSS 2.0 feed.