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.

Serious infections and neurological events with Raptiva

FDA is highlighting the risk of life-threatening infections in patients treated with Raptiva (efalizumab). Raptiva is an immunosuppressant approved as a once a week injection to treat certain adult patients with moderate to severe plaque psoriasis.

FDA has received reports of serious infections in patients treated with Raptiva, in some cases leading to hospitalization and even death. A new boxed warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.

Raptiva's label will also be updated to include data from studies of juvenile mice. This data suggest that repeated administration of Raptiva to pediatric patients may lead to permanent suppression of the immune system. Raptiva is not approved for children under 18 years of age.

Prescribers should carefully evaluate the risk/benefit profile of Raptiva for patients who may be more susceptible to these risks. Before starting Raptiva, make sure patients are up-to-date on their vaccinations. During therapy, do not vaccinate patients with live or live attenuated vaccines. Also, giving inactivated vaccines during Raptiva treatment may not produce an adequate immune response.

Patients should be taught to recognize the signs and symptoms of serious infections, as well as neurological disorders, anemia, thrombocytopenia, or the worsening of their psoriasis. If any of these signs appear, they should be told to seek immediate medical attention.

FDA is requiring Raptiva's manufacturer to submit a Risk Evaluation and Mitigation Strategy (REMS) which will include a medication guide for patients.