Exhibit
1
FDA
News
FOR
IMMEDIATE RELEASE
October
16, 2008
|
Media
Inquiries:
Rita
Chappelle, 301-827-6246
Consumer
Inquiries:
888-INFO-FDA
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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.