Parker Waichman LLP

Tysabri Getting More Scrutiny Over Brain Infection

European regulators are taking another look at Tysabri. According to The Wall Street Journal, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is concerned that Tysabri may have a higher rate of a rare brain infection called progressive multifocal leukoencephalopathy, or PML, than previously disclosed. According to the Journal, Tysabri is […]

European regulators are taking another look at <"https://www.yourlawyer.com/topics/overview/tysabri">Tysabri. According to The Wall Street Journal, the <"https://www.yourlawyer.com/topics/overview/tysabri">European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) is concerned that Tysabri may have a higher rate of a rare brain infection called progressive multifocal leukoencephalopathy, or PML, than previously disclosed.

According to the Journal, Tysabri is seen as one of the most effective MS treatments on the market, especially for those with severe cases who have few other options. In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the drug 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.

PML attacks the brain and central nervous system and is usually fatal. It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

According to The Wall Street Journal, CHMP has reported 23 cases of PML among Tysabri patients since the. The U.S. Food & Drug Administration (FDA) confirmed this number, the Journal said, and added that those cases occurred after Tysabri returned to the market in 2006. Previously, that number stood at 13.

CHMP’s Tysabri review will discuss “any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment,” the Journal said.

In September we reported that the FDA had updated Tysabri safety information to include information about cases of PML. In the update, the FDA said that the overall rate of Tysabri patients developing PML remains below the one-in-1,000 rate implied on the label. However, the agency warned that this risk “appears to increase with the number of Tysabri infusions received” and that the average number of infusions received before the diagnosis of PML was 25. The rate of PML in patients who have received at least 24 Tysabri infusions ranges from 0.4 to 1.3 per 1,000 patients, the FDA said. The safety information update did not include any labeling changes.

According to The Wall Street Journal, Biogen Idec Inc. and Elan PLC, the makers of Tysabri, and the FDA are now discussing potential label changes to reflect increased PML risk with longer-term usage.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
First time with working with parker waichman. Excellent staff will recommend to my friends and family.
Benny G.
2 months ago
5 Star Reviews 150
On the Christmas Eve of 2015 I had a car accident I felt lost and confused. I had no idea what I was going to do or how I was going to get my car fixed. My supervisor referred me Jorge Peniche who works for Parker Waichman. He came to meet me at my house the same day I spoke to him and helped me till the end of my case. I was very pleased with the lawyers and Jillian was very helpful in the process, her and Jorge were ready to answer any of my questions. Thank you Parker and Waichman!!
Fanta Jondot
5 years ago
5 Star Reviews 150
Jillian is so wonderful I really enjoyed working with her
Tericka Dash
6 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038