Raptiva, Psoriasis Drug Linked to Fatal Brain Infections, Pulled from U.S. Market
Raptiva, the drug for treatment of the chronic skin condition psoriasis, will be pulled from pharmacy shelves across the United States in the coming weeks after it was linked to incidents of a rare but most often deadly infection of the brain and nervous system.
The drug’s maker said today that it plans a phased voluntary withdrawal of Raptiva due to concerns about a link to progressive multifocal leukoencephalopathy (PML). Drug company Roche Holding AG recently paid $46.8 billion to purchase Raptiva’s maker, Genentech Inc.
“Our decision to remove Raptiva from the market reflects Genentech’s commitment to patient safety,” said Hal Barron, Genentech’s senior vice president, development and chief medical officer. “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.”
Raptiva has been approved in the U.S. since 2003 for treatment of severe to moderate psoriasis in adults who are also undergoing systemic therapy or light therapy. However, the drug’s maker, Genentech Inc., said physicians should immediately stop prescribing Raptiva for any new patients and should promptly contact patients currently receiving the drug to assess the most appropriate treatment alternatives. In some cases, patients taking the drug may be given new prescriptions for other drugs to treat psoriasis.
Raptiva will no longer be available in the United States after June 8, 2009, Genentech said. It is estimated that as many as 2,000 people in the U.S. currently take Raptiva for treatment of chronic plaque psoriasis. U.S. sales of Raptiva reached $108 million in 2008, officials said. As many as 46,000 people have been treated with Raptiva since it was approved, officials said.
In October 2008, the Food and Drug Administration ordered Raptiva’s packaging to be changed to include warnings about the risk of developing PML. Another labeling change and more warnings were ordered in March 2009. There have been three confirmed cases of PML in Raptiva patients and one patient who was treated with Raptiva and developed progressive neurologic symptoms before dying of unknown causes, officials said.
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