Exhibit
1
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
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 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.
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