Genentech Issues Dear Healthcare Provider Letter Regarding a Reported Case of PML in a Raptiva Patient
Thursday, October 02, 2008 6:04 PM
Symbols: DNA

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.


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