SOUTH SAN FRANCISCO, Calif.—Genentech Inc. announced April 8 that it is withdrawing the psoriasis drug Raptiva (efalizumab) from the United States market because of an increased risk of progressive multifocal leukoencephalopathy (PML), a rare but fatal disease of the central nervous system.
The withdrawal comes two months after the U.S. Food and Drug Administration (FDA) issued a warning about Raptiva's connection to PML, a rare, progressive, demyelinating disease of the central nervous system that leads to death or severe disability. There have been three reported cases of diagnosed PML in patients receiving Raptiva, and one patient treated with Raptiva who developed progressive neurologic symptoms died of unknown cause. It is not known whether other, unreported cases have occurred.
Raptiva's prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML. Genentech further updated the prescribing information last month to include additional warnings about the risk of PML.
Raptiva will no longer be available after June 8, but Genentech said "Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives."
Genentech recently decided not to develop Raptiva in transplant indications. In February, Regulators in Europe, where the drug is distributed by Merck Serono SA, recommended pulling the drug. Canada has also halted sales of Raptiva.
"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety, said Dr. Hal Barron, Genentech's chief medical officer and senior vice president of development, in a statement. "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."
Used to treat chronic, moderate to severe plaque psoriasis in adults, Raptiva registered $108 million in U.S. sales last year. According to Genentech, approximately 46,000 patients worldwide have been treated with Raptiva since the FDA approved it in 2003. Genentech estimates that approximately 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis.
Swiss drug maker Roche Holding AG, which completed its $46.8 billion acquisition of Genentech last month, said it expects to post a charge of about $125 million in the first half of the year, but beyond that, the withdrawal won't have a significant impact on its net income.
However, according to a Reuters report, the withdrawl may have other financial ramifications. According to the report, Xoma Ltd., an antibody developer in Berkeley, Calif., receives royalty payments on sales of Raptiva, which are used in part to secure a $55 million loan facility from Goldman Sachs & Co. Xoma said last month that it is negotiating the terms of its loan covenant with Goldman Sachs, but should the withdrawl put Xoma at risk of breaking the loan's covenants, Goldman Sachs could accelerate repayment of the loan.
The withdrawal comes two months after the U.S. Food and Drug Administration (FDA) issued a warning about Raptiva's connection to PML, a rare, progressive, demyelinating disease of the central nervous system that leads to death or severe disability. There have been three reported cases of diagnosed PML in patients receiving Raptiva, and one patient treated with Raptiva who developed progressive neurologic symptoms died of unknown cause. It is not known whether other, unreported cases have occurred.
Raptiva's prescribing information was updated in October 2008 to include a boxed warning on the risk of serious infections, including PML. Genentech further updated the prescribing information last month to include additional warnings about the risk of PML.
Raptiva will no longer be available after June 8, but Genentech said "Effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving Raptiva to assess the most appropriate treatment alternatives."
Genentech recently decided not to develop Raptiva in transplant indications. In February, Regulators in Europe, where the drug is distributed by Merck Serono SA, recommended pulling the drug. Canada has also halted sales of Raptiva.
"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety, said Dr. Hal Barron, Genentech's chief medical officer and senior vice president of development, in a statement. "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."
Used to treat chronic, moderate to severe plaque psoriasis in adults, Raptiva registered $108 million in U.S. sales last year. According to Genentech, approximately 46,000 patients worldwide have been treated with Raptiva since the FDA approved it in 2003. Genentech estimates that approximately 2,000 patients in the United States may currently be receiving Raptiva for chronic plaque psoriasis.
Swiss drug maker Roche Holding AG, which completed its $46.8 billion acquisition of Genentech last month, said it expects to post a charge of about $125 million in the first half of the year, but beyond that, the withdrawal won't have a significant impact on its net income.
However, according to a Reuters report, the withdrawl may have other financial ramifications. According to the report, Xoma Ltd., an antibody developer in Berkeley, Calif., receives royalty payments on sales of Raptiva, which are used in part to secure a $55 million loan facility from Goldman Sachs & Co. Xoma said last month that it is negotiating the terms of its loan covenant with Goldman Sachs, but should the withdrawl put Xoma at risk of breaking the loan's covenants, Goldman Sachs could accelerate repayment of the loan.
