Genentech recalls psoriasis drug Raptiva on concerns of fatal brain infection

Over 46,000 people have been treated with Raptiva (efalizumab) worldwide

Genentech Inc has started withdrawing its psoriasis treatment Raptiva (efalizumab) from the US market on fears that Raptiva can cause a very dangerous brain disease.

About 2,000 US patients may be taking Raptiva for hronic plaque psoriasis and roughly 46,000 have been treated with the drug since it was approved in 2003., Genentech, the biotechnology company acquired last month by Swiss drugmaker Roche Holding AG, said. Roche owned 56% of Genentech but decided last July to buy out the rest.

Genentech has told doctors not to write prescriptions for new patients and to contact those already on the drug to discuss alternative therapies as part of a phased withdrawal of Raptiva to be completed by June 8.

“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,” a Genentech statement said.

The psoriasis drug efalizumab (Raptiva) is posing the risk of progressive multifocal leukoencephalopathy (PML), Genench said. Progressive multifocal leukoencephalopathy (PML) is caused by the reactivation of a common virus in the central nervous system of immune-compromised individuals. Polyomavirus JC (often called JC virus) is carried by a majority of people and is harmless except among those with compromised immune systems.

The rare disease occurs, rarely, in organ transplant patients; people undergoing chronic corticosteroid or immunosuppressive therapy; and individuals with cancer, such as Hodgkin’s disease, lymphoma, and sarcoidosis. There is no known effective treatment for PML.

Raptiva, a once-weekly injection, suppresses the immune system to reduce psoriasis flare-ups, but this can increase the risk of serious infections and malignancies, experts noted. Raptiva is a relatively minor product in the company’s portfolio, with $108 million in US sales last year.

Plaque psoriasis, an autoimmune skin disease that is unsightly, uncomfortable and in some cases debilitating.

In its advisory, the FDA “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.” “Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms,” the advisory recommended.

Genentech was also required to distribute a medication guide with all prescriptions to inform users of the potentially fatal risk. In February 2009, a recall of Raptiva was issued in Canada and Europe due to the risk of PML infection, and the FDA indicated at that time that they were continuing to review the latest information to determine whether additional regulatory actions should be taken in the United States.

Outside experts, however, said at the time that, though the news was serious, there was no reason to panic. Srikanth Kolluru, an assistant professor of pharmaceutical sciences at Texas A&M Health Science Center, said that people “who are on this medication currently should be made aware that it might cause brain infection or any other infections and possible symptoms so that they can contact their  physician immediately.” People using the drug “need to be well-informed about the symptoms for PML infection and need to be monitored closely,” he said.

The move comes only about six months after the company updated the drug’s labeling to carry warnings of links to progressive multifocal leukoencephalopathy.