PML News

Positive JCV Test Found As New Risk Factor for PML

Posted on February 22, 2012

Testing positive for anti-JC virus (JCV) antibodies is a newly identified risk factor for a rare, but serious brain disorder associated with the drug Tysabri® (natalizumab), according to a U.S. Food and Drug Administration (FDA) Safety Announcement.

Tysabri® is prescribed to treat multiple sclerosis or Crohn’s disease. Progressive multifocal leukoencephalopathy (PML) is a rare brain infection in which the coating of some brain nerve fibers called myelin is damaged. Tysabri® has been associated with increasing the risk of getting PML.

Two hundred and one patients with PML have been reported among about 96,582 patients given Tysabri® worldwide through Jan. 4, 2012. Patients who have taken Tysabri® for between 25 and 48 months number 11 in 1,000 if they have been treated previously with an immunosuppressant.

Doctors and patients are warned in the FDA announcement to carefully weigh the risks versus the benefits of continuing treatment with Tysabri® in patients who have:

  • JCV antibodies
  • Been treated longer with Tysabri®, especially longer than two years
  • Have had prior treatment with an immunosuppressant drug such as mitoxantrone, azathioprine, methotrexate, cyclophosphamide, or mycophenolate mofetil.

The risk of getting PML is greatest if you have all three known risk factors.

The new information has been added to the Tysabri® drug label. A new anti-JCV detection test was approved by the FDA on January 20, 1012.

Because of this new information, your doctor may recommend a blood test to see if you have ever been exposed to JCV, which is the virus that causes PML. This test measures the presence of antibodies to the virus. These antibodies often are called anti-JCV antibodies.

PML symptoms are varied and progress over a matter of days to weeks. They include

  • Progressive weakness on one side of the body
  • Clumsiness
  • Disturbed vision
  • Changes in thinking, memory and orientation, leading to confusion and personality changes

The progression of the disease can lead to death or severe disability over weeks or months.

For more information, contact a progressive multifocal leukoencephalopathy lawyer today.

New Antibody Test Shown to Indicate PML Risk

Posted on January 23, 2012

If you test positive for having antibodies to the JC virus (JCV), you have an increased risk of getting progressive multifocal leukoencephalopathy (PML), according to a Food and Drug Administration (FDA) Safety Communication released Jan. 20, 2012.

PML is a rare serious infection of the brain that occurs in patients treated with Tysabri® (natalizumab) for multiple sclerosis (MS) or Crohn’s disease.  Patients and their doctors should discuss the risks and benefits of taking Tysabri® for MS or Crohn’s disease.

There are three risk factors for PML. A patient having all three has of getting PML of 11 in 1,000. The three risk factors are:

  • The presence of anti-JCV antibodies
  • Long-time treatment with Tysabri®, in particular longer than two years
  • Prior treatment with an immunosuppressant medication

Patients should talk with their physicians if they develop symptoms that characterize PML. Symptoms vary and become worse over a period of days or weeks. These symptoms include progressive weakness on one side of the body, clumsiness, problems seeing, changes in thinking, memory and orientation that end in confusion and personality changes.

If you test positive for the presence of anti-JCV antibodies, you have been exposed to JCV in the past.

The drug label accompanying a Tysabri® prescription reflects this new information.

The nerve fibers of patients with PML have been damaged. It is a rare disease that does not harm people with normal-functioning immune systems. People with weakened immune systems are more susceptible to the disorder, in particular people who are immunodeficient due to having HIV infection (the human immunodeficiency virus); having leukemia or lymphoma; taking Tysabri®.

It still is possible to be at risk for developing PML, even if you test negative for anti-JCV antibodies. This is because it is possible to get a new JCV infection or for test results to be inaccurate.

Sources:

For more information, contact a PML lawyer today.

FDA Clears Phase II Trial of Drug to Treat JC Virus

Posted on August 16, 2011

The pharmaceutical company Inhibikase Therapeutics has received a green light from the U.S. Food and Drug Administration (FDA) to conduct a phase II clinical trial on a drug to treat the JC virus. The authorization to do the study is significant because the JC virus causes a deadly brain disease that occurs in patients with compromised immune systems.

The trial is called a “proof of concept” trial.  “Proof of concept” trials are done in the early stages of human drug testing to see if the basic reason for the drug’s working and doing so safely can be substantiated.

The JC virus is a dormant virus living in between 80 to 90 percent of adults.  It remains harmless unless it is triggered by some assault on the patient’s immune system.  When this happens, the virus is activated, travels through the bloodstream to the brain, and begins to destroy brain cells. The disease it unleashes is called progressive multifocal leukoencephalopathy (PML).

PML kills most of its victims within 1 to 9 months. The average lifespan after diagnosis is 6 months.  Those who survive are left with significant neurological deficits.

The JC virus is activated, leading to PML, in patients with AIDS, HIV, and others with compromised immune systems, including people on chemotherapy for cancer, and patients receiving immunosuppressive drugs for organ transplants, rheumatoid arthritis, system lupus erythematosus, Crohn’s disease, severe plaque psoriasis, and multiple sclerosis.

The drug being tested is called Ik T-001.  If it succeeds in combatting the JC virus before the virus is activated and sets off PML, the drug would be a life saver for many patients with comprised immune systems and those on drugs to treat autoimmune diseases (diseases in which the immune system attacks the body).

Inhibikase Therapeutics was founded in 2008.  It is developing early-stage drugs to treat viral and bacterial diseases and opening new avenues for vaccine development and biodefense.

Elan Profits Nearly Triple Thanks to MS Drug Sales

Posted on July 27, 2011

Second-quarter profits for the Irish drug company Elan came close to tripling due to hefty sales of Tysabri®, its drug to treat multiple sclerosis.

Elan co-markets the drug with Biogen.  Biogen issued higher than expected quarterly figures for Tysabri® in July, indicating the number of new users increased at the highest rate in over a year.

“We are making progress across all aspects of our company,” said Chief Executive Kelly Martin.

“Tysabri® continues to grow in double-digits,” he said. “Demand for the product is strong both in the U.S. and outside the U.S.”

The company makes an added $100 million every time 10,000 more patients buy Tysabri®. It is expected that the medication will increase the overall growth in the company’s bottom line by 15 percent annually for the next three to five years.

Tysabri® (the generic is natalizumab) is a monoclonal antibody. It was approved in November 2004, but pulled from the market several months later when a few patients taking the medication to treat multiple sclerosis contracted a fatal brain infection, progressive multifocal leukoencephalopathy (PML).

PML is a lethal viral disease of the brain. The virus, known as the JC virus, remains latent in the human body until it overcomes a weakened immune system.  Once in the brain, it begins to destroy the myelin covering of the nerve cells.  Progressing in an inexorable downward spiral, PML kills most victims within an average of six months.

Tysabri® was released back onto the market in June 2006 with onerous restrictions on who could use the drug.  Patients had to be enrolled in and were monitored by a strict “risk mitigation strategy” to keep track of any possible symptoms of PML in Tysabri® patients. The strategy helped physicians know more about and manage the risks of PML in their patients.

One In 25,000 Patients Treated with Rituxan Risk PML

Posted on May 11, 2011

An arthritis patient on the medication Rituxan™ faces a one in 25,000 chance of getting the deadly brain disease progressive multifocal leukoencephalopathy (PML), according to researchers at Washington University in St. Louis.

David B. Clifford, M.D. and his co-workers published their report in an online issue of Archives of Neurology. The group found four cases of PML in approximately 129,000 patients taking Rituxan™ (the generic is rituximab) for rheumatoid arthritis.

Among the four, two patients died within a year of diagnosis of PML. Of the two remaining patients, whose Rituxan™ treatment was stopped, one had no further symptoms of PML and the other, although cognitively impaired, has regained her ability to walk.

The researchers urged physicians treating patients with Rituxan™ to think twice about prescribing the drug because of the lethality of PML. In those patients who are treated with the medication, doctors should know that "aggressive evaluation of new and progressing neurological deficits is very important to allow early diagnosis. No further rituximab should be used if a suspicious neurological symptom or sign appears until the diagnosis is successfully excluded," the authors urged.

PML is a disease of the brain, caused by the J.C. virus. The virus exists in 80 to 90 percent of adults and remains latent until the immune system is weakened. The opportunistic infection then travels through the blood stream to the brain, where it inexorably progresses to destroy the myelin.  Myelin is a substance that covers the nerves, protecting them and enabling them to transmit signals faster to the rest of the body.

With the destruction of the nerves, patients with PML experience unrelenting diminishment of their capacities.  The first sign of the disease is usually clumsiness.  Progressing slowly at first, the disease continues to destroy brain tissue and with it the concomitant function of the body parts and organs that are affected.

The disease attacks patients with HIV and AIDS and others with immune system deficiencies, caused either by disease or by drugs used to treat disease. Victims include patients on chemotherapy for cancer and patients receiving immunosuppressive drugs for organ transplants, rheumatoid arthritis, systemic lupus erythematosus, Crohn’s disease, severe plaque psoriasis, and multiple sclerosis.

If you’ve been diagnosed with PML and have been treated with Rituxan™, you might be eligible for compensation. Contact our PML attorneys to schedule a free case review.

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