Quoted from http://www.bloomberg.com/apps/news?pid=20601103&sid=a.soONQKbh5g
Brain Disease Found in 3rd Patient on Roche’s Rituxan
By Rob Waters
Oct. 23 (Bloomberg) -- A third arthritis patient taking Roche Holding AG and Biogen Idec Inc.’s Rituxan developed a rare and potentially fatal brain disorder, U.S. regulators said.
The 73-year-old patient, diagnosed three years ago with rheumatoid arthritis, was treated with Rituxan in February 2009, according to a letter to physicians from Biogen and Roche’s Genentech unit. She developed symptoms four to six months later and was diagnosed with the brain infection known as PML, or progressive multifocal leukoencephalopathy, according to a statement from the U.S. Food and Drug Administration.
The brain disease has been linked to the multiple sclerosis drug Tysabri marketed by Cambridge, Massachusetts-based Biogen and Irish drugmaker Elan Corp. The European Medicines Agency reported today on its Web site that the number of PML cases in Tysabri users has jumped to 23 from 13 disclosed earlier. Two fatal cases of PML have been reported in rheumatoid arthritis patients using Rituxan, which primarily treats blood cancers.
The woman was the first rheumatoid arthritis patient taking Rituxan to have contracted the brain illness who was not previously treated with a type of anti-inflammatory drug called a TNF antagonist. Basel, Switzerland-based Roche and Biogen co- market Rituxan in the U.S.
“The overall reporting incidence of PML in patients with rheumatoid arthritis receiving Rituxan is rare (3 reports in approximately 100,000 rheumatoid arthritis patients that have been exposed),” the companies said in the letter to doctors. “However, the information to date suggests that patients with RA who receive Rituxan have an increased risk of PML.”