Genentech, Inc. (NYSE:DNA) announced today that the company has issued a
Dear Healthcare Provider letter to inform potential prescribers of a
case of progressive multifocal leukoencephalopathy (PML) in a 70-year
old patient who had received Raptiva®
(efalizumab) for more than four years for treatment of chronic plaque
psoriasis. The company will work with the U.S. Food and Drug
Administration (FDA) to update the prescribing information for Raptiva
and determine if further action is needed.
"We believe it is important for healthcare providers to be aware of this
case of PML in a patient receiving Raptiva and are working with the FDA
to ensure that this information is communicated appropriately to
physicians so that physicians and their patients can make informed
treatment decisions," said Hal Barron, M.D., Genentech senior vice
president, development and chief medical officer.
The case was recently reported to the company in late September as part
of Genentech’s ongoing safety monitoring and
surveillance program. Based on the medical information available to
date, Raptiva may have had a contributory role in the development of PML
in this patient. There are no other cases of confirmed PML in patients
treated with Raptiva. There has been a report of a 62-year old patient
treated with Raptiva who developed progressive neurologic symptoms and
died of unknown cause. Information about this other case is also
included in the Dear Healthcare Provider letter issued today.
Patients who are currently on Raptiva therapy or considering Raptiva
should discuss the benefits and risks of Raptiva with their physicians.
As described in the Raptiva package insert, some patients have had
severe worsening or new forms of psoriasis while taking Raptiva or after
stopping Raptiva. It is important for patients not to change or stop
treatment without first talking with their physician.
The Dear Healthcare Provider letter has been posted to the Genentech web
site and is available along with the current package insert including
Raptiva safety information by clicking the Raptiva link at http://www.gene.com/gene/products.
About PML
PML is a rare, progressive, demyelinating disease of the central nervous
system that usually leads to death or severe disability. PML is caused
by activation of the John Cunningham, (JC) virus. JC virus resides in
latent form in up to 80 percent of healthy adults, typically only
causing PML in immunocompromised patients.