The go comes nearly two months after U.S. shape officials issued a public shape advisory on the drug after confirming a link to a rare, sometimes fatal brain infection.

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.”

Genentech estimated that approximately 2,000 patients in the United States may currently be using Raptiva (efalizumab) for chronic tablet psoriasis.

In view of the fact that it was ordinary by the U.S. Food and Drug Administration in 2003, approximately 46,000 patients worldwide have been treated with Raptiva, the company said.

“Our choice to remove Raptiva from the market reflects Genentech’s
commitment to patient protection,” said Dr. Hal Barron, Genentech’s older vicepresident, 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 ordinary has
significantly changed.”

In February, an FDA advisory noted there had been three deaths of people taking the drug. Two involved people with inveterate cases of a rare brain infection called progressive multifocal leukoencephalopathy (PML).

The third death was a person believed to have contracted the brain infection, according to the advisory.

All had been treated with Raptiva for at least three years, and none was taking other immune suppressants.

In its advisory, the FDA said it would examine the issue carefully and
“fervently recommends that shape 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 shape care professionals immediately if they experience any such symptoms,” the advisory recommended.

Outside experts, but, said at the time that, though the news was
serious, there was no reason to panic.

“Patients should talk to their doctors and carefully weigh the risks and
benefits of Raptiva, taking into tab the most recent bit of information, ” said Bruce Bebo Jr., director of research for the National Psoriasis Foundation in Portland, Ore.

Srikanth Kolluru, an assistant professor of pharmaceutical sciences at Texas A&M Shape Science Center, said that people “who are on this medication currently should be made aware that it might cause brain infection [PML] 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.

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. PML is caused by a virus.

Psoriasis is an autoimmune disease that usually shows up on the skin and can also manifest as psoriatic arthritis, according to the National Psoriasis Association.

Genentech said Wednesday that it was working with Merck Serono, its licensee outside the United States and Japan, to inform other regulatory authorities of the drug’s withdrawal from the U.S. market.

For a safe and effective treatment visit the PsoriasisCure.net site.

Raptiva may cause a serious brain infection called progressive multifocal leukoencephalopathy.

The Food and Drug Administration cited three inveterate cases, and a possible fourth, of people diagnosed with progressive multifocal leukoencephalopathy (PML) after life treated with Raptiva.

“Three of those patients have died,” the FDA said in a public shape advisory. “All four patients were treated with the drug for more than three years.”

None was receiving other treatments that suppress the immune system.

Raptiva’s product labeling was revised in October to highlight a boxed warning about the risks of life-threatening infections, including PML.

“At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation approach (REMS) to contain a medication guide to educate patients about the drug’s risks,” the FDA’s advisory says.

In the advisory, issued Thursday, the FDA highlighted the inveterate cases and promised to “take appropriate steps” to ensure that Raptiva’s risks do not outweigh its benefits.

The FDA also said it will ensure that patients “are clearly informed of the signs and symptoms of PML” and that shape care professionals “carefully monitor patients for the possible development of PML.”
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Overseas, the European Medicines Agency has gone further, recommending that no new prescriptions for Raptiva be issued and that patients taking the drug talk to their doctors about an alternative.

On Thursday it questioned the European Commission to make that recommendation legally binding.

The group’s Committee for Therapeutic Products for Human Use determined “that the benefits of Raptiva no longer outweigh its risks, because of protection concerns, including the occurrence of progressive multifocal leukoencephalopathy in patients taking the medicine.”

It said patients who have been treated with the drug should be “closely monitored for neurological symptoms and symptoms of infection.”

“Patients who are currently taking Raptiva should not stop treatment abruptly, but should make an appointment with their doctor to discuss the most appropriate replacement treatment,” the agency said.

Raptiva, a once-weekly injection for adults with moderate to severe tablet psoriasis, works by suppressing T-cells — cells that help fight infection — in the immune system. Those cells cause the skin inflammation associated with psoriasis.

By suppressing T-cells, Raptiva “decreases the function of the immune system, which increases a patient’s susceptibility to infections,” the FDA said.

The National Institutes of Shape says the prognosis for PML “remains grim; the disease usually lasts for months and 80 percent die within the first six months, although spontaneous improvement has been reported. Those who survive PML can be left with severe neurological disabilities.”

Around 6 million to 7 million Americans have psoriasis, which is incurable, the NIH says.

For a safe, inexpensive, psoriasis treatment visit the PsoriasisCure.net website.