It's the start of a long goodbye for Genentech's psoriasis remedy Raptiva. The company said it's phasing out the drug because of recent reports of the potentially fatal brain infection progressive multifocal leukoencephalopathy, or PML, in some patients.
The pullback won't be a huge hit for the company, which was bought out by longtime partner Roche last month. Raptiva clocked some $108 million in 2008 sales in the U.S., and Roche says it will take a $125 million charge for the withdrawal. It's not expected to change the Swiss drugmaker's 2009 financial forecasts.
Genentech had already updated Raptiva's label to include a warning of PML risk. But the company decided to pull the drug completely because it figured the risk wasn't worth it. "Although we believe that many psoriasis patients are benefiting from Raptiva," Genentech chief medical officer Hal Barron said in a statement, "the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed."
PML is the rare infection that has dogged more than one high-tech drug. Biogen Idec and Elan's multiple sclerosis treatment Tysabri is the best known example: That drug was withdrawn after PML cropped up in some patients, then reintroduced under a risk management program. A handful of Tysabri patients have developed PML since the reintroduction. Biogen and Genentech's Rituxan has also been linked with PML when used in lupus patients. Currently, Biogen is testing an old malaria pill as a potential treatment for PML.
- read the Genentech statement
- see the FDA release
- read the story in the Los Angeles Times