Daavlin

FDA Statement

FDA Statement

FOR IMMEDIATE RELEASE

Statement: April 8, 2009
Media Inquiries: Rita Chappelle, 301-796-4672
Consumer Inquiries: 888-INFO-FDA

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 theU.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 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.


FDA Statement

FOR IMMEDIATE RELEASE

Statement: Feb. 19, 2009
Media Inquiries: Rita Chappelle, 301-796-4672
Consumer Inquiries: 888-INFO-FDA

FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

The FDA is reviewing this latest information. The agency will take appropriate steps to:
• ensure that the risks of Raptiva do not outweigh its benefits;
• that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
• that health care professionals carefully monitor patients for the possible development of PML.

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.

The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

–Online: www.fda.gov/MedWatch/report.htm
–Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD20852-9787
–Fax: (800) FDA-0178
–Phone: (800) FDA-1088


European Medicines Agency Press

Office 7 Westferry Circus, Canary Wharf, London
UK Tel. (44-20) 74 18 84 00
Fax (44-20) 74 18 84 09
E-mail:mail@emea.europa.eu http://www.emea.europa.eu

 

London, 19 February 2009
Doc. Ref. EMEA/CHMP/20857/2009

PRESS RELEASE

European Medicines Agency recommends suspension of the marketing authorisation of Raptiva (efalizumab)

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine.

Raptiva has been authorised in the European Union (EU) since September 2004 to treat adult patients with moderate to severe chronic plaque psoriasis (a disease causing red, scaly patches on the skin), who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).

The CHMP reviewed the medicine at the request of the European Commission, following reports of serious side effects, including three confirmed cases of PML in patients who had taken Raptiva for more than three years. PML is a rare brain infection that usually leads to severe disability or death. Two of the three confirmed cases of PML reported to the CHMP resulted in the patient’s death. The CHMP also received an additional report of a suspected case of PML, which could not be confirmed.

Following review of all available data on the medicine’s safety and effectiveness, the CHMP concluded that:

Raptiva’s benefits are modest;

in addition to PML, Raptiva is associated with other serious side effects, including Guillain-Barré and Miller-Fisher syndromes, encephalitis, encephalopathy, meningitis, sepsis and opportunistic infections (infections occurring in people with compromised immune systems);

there is not enough evidence to identify a group of patients in which the benefits of Raptiva outweigh its risks, in particular there is a lack of data on effectiveness and safety in patients who have no other treatment options and who may already have a weakened immune system as result of previous treatments.

The CHMP was therefore of the opinion that the risks of Raptiva outweigh its benefits and that the marketing authorisation for this medicine should be suspended in the EU.

Prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives. They should make sure that patients who have been treated with Raptiva are closely monitored for neurological symptoms and symptoms of infection. Patients who are currently taking Raptiva should not stop treatment abruptly, but should make an appointment with their doctor to discuss the most appropriate replacement treatment.

The EMEA’s recommendation has been sent to the European Commission for the adoption of a legally binding decision.


 

FDA Statement

FOR IMMEDIATE RELEASE

Statement: October 16, 2008
Consumer Inquiries: 888-INFO-FDA

FDA Approves Updated Labeling for Psoriasis Drug Raptiva

Safety concerns drove labeling changes

The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA’s post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA’s Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

Additionally, Raptiva’s label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

“As part of FDA’s monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling,” said Janet Woodcock, the FDA’s director of the Center for Drug Evaluation and Research. “Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks.”

Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body’s natural defense system, it can also increase the risk of serious infections and malignancies in patients.

Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug’s use.

One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

Consumers and health care professionals can 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.

Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

 

Information gathered from MedWatch at FDA.gov