A potentially deadly brain infection has reared its head in another drug population. This time, Genentech is warning doctors that a patient treated with its psoriasis drug Raptiva has developed progressive multifocal leukoencephalopathy, or PML. It's the second time in a month that Genentech has seen PML crop up among its patients; in September, a rheumatoid arthritis patient taking Rituxan died from the same infection.
And as you know, it's the same brain malady that has plagued Biogen Idec and Elan: It forced the multiple sclerosis drug Tysabri off the market until Biogen and FDA agreed on a strict risk-management program. Since then, two new cases have emerged, but though the FDA is adding that info to Tysabri's label, it deemed any further regulatory action unnecessary.
The latest PML case was reported to Genentech late last month as part of its safety monitoring program. "[B]ased on the medical information available to date, Raptiva may have had a contributory role in the development of PML in this patient," Genentech said. The company's overseas partner, Merck Serono, said it has let other regulatory agencies know about the case and is working with European watchdogs to update Raptiva's product info.
- see Genentech's release
- read the story at PharmaTimes