Genentech Inc. said yesterday it is withdrawing psoriasis drug Raptiva from the US market because of an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
The move comes nearly two months after South San Francisco-based Genentech, a wholly owned subsidiary of Swiss drugmaker Roche since its acquisition in March (See: Roche clinches Genentech deal for $47 billion), after the US Food and Drug Administration issued a warning about Raptiva's connection to PML. The FDA had originally approved Raptiva in 2003.
In its advisory, the FDA said it would study the issue carefully and "strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment."
Regulators in Europe, where the drug has been distributed by Merck Serono, in February recommended pulling the drug off shelves. Canada also has halted sales of the drug.
In a prepared release, Genentech said Wednesday, "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. Raptiva will no longer be available after June 8, 2009."
"Our decision to remove Raptiva from the market reflects Genentech's commitment to patient safety," said Dr. 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."
There have been three cases of diagnosed PML in patients receiving Raptiva and one patient treated with Raptiva who developed progressive neurologic symptoms and died of unknown causes. It is not known whether other, unreported cases have occurred, Genentech said.
PML is a rare, progressive neurologic disease caused by a virus that affects the central nervous system. It typically occurs in people whose immune systems have been severely weakened. There is no known treatment.
Raptiva - which registered sales of $242 million last year, including $108 million by Genentech - has been used to treat chronic moderate to severe plaque psoriasis in adults 18 years or older.
Genentech estimates that approximately 2,000 patients in the US may currently be receiving Raptiva for chronic plaque psoriasis. Since FDA approval in 2003, approximately 46,000 patients worldwide have been treated with Raptiva.