PML Risk Forces Maker of Raptiva To Withdraw Drug

On April 8, 2009, drug manufacturer Genentech, initiated the first steps in removing its controversial drug Raptiva, which is prescribed to treat Psoriasis from the U.S. market. The move comes almost two months after FDA officials issued a public health advisory on the drug after confirming a link to a rare, and sometimes fatal brain infection.

In a prepared release, Genentech said on April 8, 2009, “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 (generic: efalizumab) for chronic plaque psoriasis. Since it was approved by the FDA in 2003, an estimated 46,000 patients worldwide have been treated with Raptiva, the company said.

“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.”

In February 2009, an FDA advisory noted there had been three deaths of people taking the drug. Two of those people had confirmed 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 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.”

“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.

Outside experts, however, 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 account the most recent bit of information,” said Bruce Bebo Jr., director of research for the National Psoriasis Foundation in Portland, Oregon.

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 [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 also said on April 8, 2009 they are also 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.