Genentech, Inc. (NYSE:DNA) announced today that the company has issued a
Dear Healthcare Provider letter to inform dermatologists and
neurologists of a 2nd case of progressive multifocal
leukoencephalopathy (PML) which resulted in the death of a 73-year old
woman who had received Raptiva® (efalizumab) for
approximately four years for treatment of chronic plaque psoriasis.
Based on the medical information available for the two cases of PML,
which occurred in one 70-year old patient and one 73-year old patient
who received Raptiva for approximately four years, Genentech believes
that Raptiva likely increases the risk of PML and that prolonged
exposure to Raptiva and older age may further increase this risk. The
company is working with the U.S. Food and Drug Administration (FDA) to
determine the appropriate next steps.
The Raptiva prescribing information was updated in October 2008 to
include a boxed warning on the risk of serious infections, including PML
in patients receiving Raptiva. A Dear Healthcare Provider letter was
issued in early October to inform healthcare providers of the first
reported case of PML. This second case of PML in a
Raptiva-treated patient was recently reported to the company in late
October as part of Genentech’s ongoing safety monitoring and
surveillance program.
"Given the seriousness of PML and its rarity in the general population,
it is important to inform healthcare providers of this second reported
case in a Raptiva-treated patient, so that physicians and their patients
are equipped to make informed treatment decisions," said Hal Barron,
M.D., Genentech senior vice president, development and chief medical
officer.
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 to talk with their
physician before changing or stopping their treatment.
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.
