Why Raptiva was Withdrawn

Daly City, CAAfter getting FDA approval in 2003, Raptiva was used to treat about 46,000 patients worldwide. In April, Genentech's immunosuppressant for psoriasis was withdrawn from the market after it was associated with progressive multifocal leukoencephalitis (PML)—a rare brain disease. So far only three cases have been associated with the drug, but PML is often undiagnosed or misdiagnosed. And given the amount of patients prescribed Raptiva, the drug may be withdrawn but we likely haven't heard the last of it…

To make matters worse, Tysabri, a similar drug that is sold by Biogen and Elan Corp., has been linked to 10 PML cases going back to 2005. It was withdrawn from the market but is available again.

And another similar drug called Rituxan--co-marketed by biotechnology companies Genentech Inc. and Biogen Idec Inc. and used to treat lymphoma, a cancer of immune-system cells--is also suspected to be linked to PML. In one study called RADAR, researchers said they found 22 previously unreported cases of PML by contacting cancer treatment centers. In March 2009 the medical journal Blood released a study that linked Rituxan to 57 cases of PML, between 1997 and 2008.

Doctors say Rituxan is also used "off label" for conditions not approved by the FDA, including lupus and psoriasis. FDA officials say they are aware of some off-label uses and they are legal, so long as the drug maker does not promote them.

So why has Raptiva been withdrawn yet Rituxan and Tysabri stay on the market?

"It might have been OK for efalizumab [Raptiva] to be around — with a giant warning label and clear-cut informed consent for use in very specific situations," said Craig L. Leonardi, M.D., clinical professor of dermatology, Saint Louis University. "But [Genentech] has the right to stop the distribution and manufacture of the drug at any time." He adds that such decisions depend on the disease being treated and the doctors prescribing the medication.

"Dermatology was not very motivated to keep efalizumab around for their tough-to-treat patients who needed it. Even though psoriasis can be horrific, it's not the same as MS or cancer," said Leonardi. "So dermatology made that risk-and-benefit assessment and voted with its feet." As well, alternative medications are available to treat psoriasis. Clearly the Raptiva risk outweighs the benefit—although psoriasis can be a serious illness, it is not life-threatening. Tysabri, for example, is used to treat patients with MS and patients who have failed other therapies.

Eric Le Berrigaud, pharmaceutical equity analyst with Raymond James Euro Equities in Paris, said that Roche, which now controls Genentech, decided not to pursue Raptiva rights outside the United States. "Roche does not believe in the product, and, whatever happens, will not reintroduce the drug in the United States," said Le Berrigaud.

Raptiva's withdrawal is no comfort to psoriasis patient Luis G. His dermatologist prescribed the drug and Luis took it for about two years. "I didn't feel good, it was too intense and I wanted to get off it," says Luis. "My feet were swollen, I was aching all over and really exhausted.

"My joints hurt so much I was in agonizing pain; my dermatologist told me to stop Raptiva and he put me on an alternative psoriasis medication which is also used for arthritis. I went through two months of hell. It was driving me crazy.

The symptoms started to calm down but I was really upset when I realized this Raptiva was still in my system. This is not right, especially for something cosmetic. You get on this med and all of a sudden you can get a life-threatening disease? I was also misinformed.

When I found out that Raptiva was recalled, I just knew it in my gut that something was wrong, as soon as I started to have these adverse effects. What will happen to me down the line? I have a two-year-old girl and I am concerned; it should never have been on the market in the first place."