Second case of PML reported in patient treated with Genentech’s Raptiva

Posted on 18 November 2008

Genentech on Monday reported a second case of progressive multifocal leukoencephalopathy (PML) which resulted in the death of a 73-year-old patient who had been treated with Raptiva (efalizumab) for about four years for chronic plaque psoriasis. The case follows another that was reported in October involving a 70-year-old patient who died after taking the drug for approximately the same length of time.

The company said that the medical information available for both cases suggests that the drug “likely increases the risk of PML and that prolonged exposure to Raptiva and older age may further increase the risk.” Genentech noted that the drug’s prescribing information was updated in October to include a boxed warning about the risk of serious infections, including PML, in patients who take Raptiva, and indicated that it is working with the FDA to determine what steps to take next.

Commenting on the development, Cowen and Co. analyst Eric Schmidt remarked that the latest case was “not shocking” given the previously reported instance of PML.

Raptiva, which is approved for the treatment of plaque psoriasis, garnered $107 million in US sales last year.

Source: FirstWord

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