April 8, 2009 - The psoriasis drug Raptiva has been voluntarily pulled from the market, drugmaker Genentech announced today.
Raptiva suppresses the haywire immune responses that cause psoriasis. But this immune suppression sometimes allows a fatal infection, progressive multifocal leukoencephalopathy or PML, to grow in the brain.
There have been three known and one suspected PML deaths in patients taking Raptiva. Last month, the company strengthened its "black box" warning in the wake of an FDA-issued public health advisory that the drug could trigger PML.
"Although we believe that many psoriasis patients are benefiting from Raptiva, the balance between benefit and risk in the psoriasis population for which Raptiva was approved has significantly changed," Genentech Chief Medical Officer Hal Barron, MD, says in a news release.
Some 2,000 U.S. patients are taking Raptiva. Their doctors will be warned to wean them off the drug and switch them to a new medication. The drug will no longer be available after June 8, but the company will provide enough of the drug to see patients through a brief transition period.
Worldwide, some 46,000 patients have received Raptiva treatment.
PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death.
PML symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking, and personality changes.