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

Wednesday, April 08, 2009 4:33 PM

Genentech, Inc. announced today a phased voluntary withdrawal of the psoriasis drug Raptiva^®(efalizumab) from the U.S. market. The company’s decision is based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.

Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives. Raptiva will no longer be available after June 8, 2009. This transition period is intended to allow patients, who are currently taking Raptiva, enough time to work with their doctors to appropriately discontinue use of Raptiva. Because of the potential for severe psoriasis worsening with abrupt discontinuation of Raptiva, it is important that patients talk with their doctor before stopping treatment.

Genentech estimates that approximately 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis. Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva.

“Our decision to remove Raptiva from the market reflects Genentech’s commitment to patient safety,” said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed.”

The Raptiva prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML, in patients receiving Raptiva. The Raptiva prescribing information was further updated in March 2009 to include additional information on the risk of PML and a new Medication Guide for patients.

There have been three cases of diagnosed PML in patients receiving Raptiva and one patient treated with Raptiva who developed progressive neurologic symptoms and died of unknown cause. It is not known whether other, unreported cases have occurred.


4/24/2009 1:37:51 PM President by kevin duffy On April 8, 2009, 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 at www.fda.gov/medwatch/report.htm. More information about your rights, please visit: www.PleaseGetMeAnAttorney.com for a Raptiva Attorney or call 1-866-484-7268 Reply Rating: (0) (0)

On April 8, 2009, 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 at www.fda.gov/medwatch/report.htm.

More information about your rights, please visit: www.PleaseGetMeAnAttorney.com for a Raptiva Attorney or call 1-866-484-7268

Rating: (0) (0)

Post Comment

Name:

Alert for new comments:

Your email:

Your Website:

Title:

Comments:

Related Press Releases

Related Stories