Genentech withdraws psoriasis drug Raptiva

The psoriasis drug Raptiva is being withdrawn from the U.S. market after reports that three patients on the drug had developed a serious brain disease called progressive multifocal leukoencephalopathy (PML) that is almost always fatal.

A third patient on Raptiva died of a progressive neurological disorder but it is not known whether the disease was PML.

It is thought that there are 2,000 patients in the U.S. on the drug.

The drug’s manufacturer Genetech is voluntarily withdrawing the drug, which will be phased out slowly so that patients will have time to switch over to other treatments.

In the meantime, the  U.S. Food and Drug Administration is asking prescribers not to start any new patients on Raptiva.

Prescribers should “immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies,” the FDA said and strongly recommended “that patients work with their health care professional to transition to other alternative therapies for psoriasis.”

Genentech urged  patients to be sure to talk to their doctors before stopping patient because abrupt discontinuation of Raptiva can cause a severe worsening of their psoriasis.

PML is caused by a virus called Polyomavirus JC, often called the JC virus. Most people are infected with the virus druing childhood and carry it throughout life without harm.

However, the virus can become dangerous when a person’s immune defenses are lowered. This can occur when they develop a cancer, such as a lymphoma; develop an immune disorder, such as AIDS; or take drugs that suppress the immune system. 

Raptiva is the brand name of a humanized recombinant monoclonal antibody called efalizumab. It suppresses the immune system by binding to a protein on white cells.

This can help treat psoriasis a skin condition that is caused by an inflammatory reaction mediated by the immune system. But it can also reduce normal immune function allowing the reactivation of suppressed viruses such as the JC virus.

Once activated the JC virus attacks the white matter of the brain, which surrounds, support  and sustains the delicate nerve fibers through which neurons transmit their signals.

Destruction of the white matter disrupts the nerve cell function, leading to loss of coordination, weakness, and, in the case of PML, unless reversed, death.

Raptiva will no longer be available in the U.S. market on June 8, 2009, Genetech says.

To learn more:

• Read the full FDA advisory on Raptiva and Genetech’s press release below.
   
• Read the National Library of Medicine’s MedLinePlus page on Progressive Multifocal Leukoencphalopathy, which includes a list of symptoms, and its page on Psoriasis.
    
• Read the National Library of Medicine’s MedLine Plus information page on Raptiva and the information page on the Raptiva Web site of the manufacturer Genentech.
   
• Read the National Institute of Neurological Disorders and Stroke information page for additional information about  Progressive Multifocal Leukoencephalopathy.

Genentech, Inc.’s press release:

Genentech Announces Voluntary Withdrawal of Raptiva from the U.S. Market

FDA’s press release:

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market.

The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.

By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death.

There is no known effective treatment for PML.

On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva’s labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA’s MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online atwww.fda.gov/medwatch/report.htm.

More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products.

Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.

Tags: Dermatology, efalizumab, Genentech, PML, Product Recall, progressive multifocal leukoencephalopathy, Psoriasis, Raptiva

Category: Brain & Nervous System, Drugs & Medicines, Product Recall, Skin, Hair & Nail