|
On April
8, 2009, 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 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.
On February,
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.
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. The drug was approved
by the FDA in 2003; by June, 2009, Raptiva will no longer be available
in the United States. Prescribers are being asked not to initiate
Raptiva treatment for any new patients. The FDA strongly recommends
that patients
|
|
|
|
work with
their health care professional to transition to other alternative
therapies for psoriasis; also prescribers should continue to monitor
patients on Raptiva for neurologic symptoms that might represent
PML.
You can
visit www.fda.gov/bbs/topics/NEWS/2009/
New01992.htm
Efalizumab
(trade name Raptiva, Genentech, Merck Serono) is a recombinant humanized
monoclonal antibody that binds to CD11a and acts as an immunosuppressant.
It is administered once weekly by subcutaneous injection. It acts
to inhibit white blood cell migration out of blood vessels into
tissues.
Due partly
to the risks of PML, the European Medicines Agency recommended in
February 2009 that efalizumab be suspended from sales in the European
Union, deeming that its benefits no longer outweighed its risks.
Look at http://en.wikipedia.org/wiki/Efalizumab
|