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April 11, 2009: Genentech Will Withdraw Raptiva Due To PML Risk

RAPTIVA® (efalizumab) Recall:

On April 8, 2009, Genentech announced a “phased withdrawal” of its psoriasis drug, Raptiva (efalizumab), due to the risk to patients for developing a life-threatening illness known as Progressive Multifocal Leukoencephalopathy (PML)

About Progressive Multifocal Leukoencephlopathy:

Progressive Multifocal Leukoencephalopathy (PML), is a rare, but serious disease of the central nervous system caused by the virus Polyomavirus JC.  PML is life-threatening, and affects primarily individuals with weakened immune systems, for example, organ transplant patients, patients receiving corticosteroids or chemotherapy, and HIV patients. 

According the National Institutes of Health, symptoms are varied, but may include clumsiness, progressive weakness, and visual, speech, or personality changes.  The symptoms may evolve over several days to several weeks, and the progression can result in serious disability or death.  

The Risks Outweigh The Benefits: Raptiva Marketing History: 

  • 2003FDA approves Raptiva in adults with moderate to severe plaque psoriasis.

  • October 16, 2008 – Raptiva labeling revised to add “boxed warning” for the risk of life-threatening infections, including PML, in patients on Raptiva therapy.

  • 2008 – Genentech reports Raptiva sales of $108 million.

  • February, 2009 – European and Canadian regulatory authorities recommend suspension of Raptiva sales due to risks.

  • February 19, 2009 – Following reports of four PML cases, including three deaths, FDA issues Public Health Advisory informing patients and prescribers of PML risk in patients taking Raptiva.

  • March 13, 2009 – FDA approves Medication Guide for Raptiva including additional information in Raptiva's labeling regarding PML.

  • April 8, 2009Genetech initiates phased withdrawal of Raptiva in U.S. market due to increased risk of patients developing PML.

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

What Happens Now And What You Can Do:

Healthcare professionals are advised to not initiate Raptiva therapy for new patients, and to discuss with current Raptiva users alternative therapies and an appropriate means of stopping Raptiva therapy. See “Dear Heathcare Provider” letter. 

Patients are advised to not stop Raptiva therapy until they have spoken with their doctor, to avoid serious side effects.  See “Dear Patient” letter.

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