FDA ADVISORY - Updated safety information about Raptiva (efalizumab)

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FDA Public Health Advisory

19 Feb 2009

Updated Safety Information about Raptiva (efalizumab)

Since the approval of Raptiva (efalizumab) in October 2003, the FDA

has received reports of three confirmed cases and one possible case of

progressive multifocal leukoencephalopathy (PML) in patients who were

47 to 73 years of age who were using Raptiva for the treatment of

moderate to severe plaque psoriasis. Two of the patients with

confirmed PML and one patient with possible PML died. All four

patients were treated with Raptiva continuously for more than three

years. None of the patients were receiving other treatments that

suppress the immune system while taking Raptiva.

PML is a rare, serious, progressive neurologic disease caused by a

virus that affects the central nervous system. When PML occurs, it is

usually in people whose immune systems have been severely weakened and

often results in an irreversible decline in neurologic function and

death. There is no known effective treatment for PML.

Raptiva works by affecting T-cells in the immune system. The effects

of Raptiva also decrease the function of the immune system and

increase susceptibility to infections.

Raptiva was approved for the treatment of moderate to severe plaque

psoriasis in 2003. There were no cases of PML seen in the clinical

trials that supported the approval of Raptiva. At the time of

approval, a total of 2,764 patients had been treated with Raptiva. Of

those 2,764 patients, 2400 had been treated for three months, 904 for

six months, and 218 for one year or more.

In October 2008, the labeling for Raptiva was changed to highlight, in

a Boxed Warning, the risks of life-threatening infections, including

PML. In addition, FDA directed Genentech, the manufacturer of

Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or

REMS, to ensure that patients receive risk information about Raptiva.

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.

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Read the full article here:

http://www.fda.gov/cder/drug/advisory/efalizumab.htm

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