Exhibit
2
FDA
News
FOR
IMMEDIATE RELEASE
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.
--Regular
Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to
MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax:
(800) FDA-0178
--Phone:
(800) FDA-1088
Read the
FDA’s 2009 Public Health Advisory
(www.fda.gov/cder/drug/advisory/efalizumab.htm)