Raptiva: An Itch That Can Kill

Washington, DCThe road for a drug aimed at the treatment of psoriasis got a little rockier on Thursday after it was revealed the US Food and Drug Administration (FDA) has put Raptiva under the microscope after the drug was potentially linked to 3 deaths. In 2008 a black box warning was ordered. Two days ago the FDA revealed in a statement, "appropriate steps to ensure that the risks of taking Raptiva do not outweigh its benefits."

Insiders interpret that statement, according to a report from the Los Angeles Times, as a potential signal for the possible withdrawal of Raptiva from the market.

Raptiva (efalizumab) was approved by the FDA for the treatment of psoriasis, a skin condition that is characterized by itching, bleeding and overall skin pain. In 2003 the makers of Raptiva, Genentech, submitted to the FDA the statement that "ongoing therapy with Raptiva provides extended benefit, with no increase in adverse events as exposure is prolonged."

However that statement may well be challenged, given that the 3 Raptiva patients who died had all been taking the drug for at least 3 years. The deaths were caused by a rare brain infection called progressive multifocal leukoencephalopathy (PML). A fourth fatal infection is reportedly also under investigation by the FDA, to determine whether or not it is also linked with Raptiva.

PML is considered what is commonly referred to in medical circles as an opportunistic infection. People most susceptible are those who suffer from AIDS, cancer or transplant patients, or those with compromised immune systems for whatever reason.

The cautionary note with regard to opportunistic infection has been addressed before, and lay at the foundation of the black box warning from 2008. The latter suggested that Raptiva carries risk for a number of opportunistic infections, including bacterial sepsis, viral meningitis and invasive fungal disease.

While PML is rare, the FDA is nonetheless treating it seriously.

It should be noted, according to the LA Times report, that Raptiva doles not represent a huge source of revenue for Genentech. Sales in 2008—the year the black box warning was added—totaled $108 million. Such sales are considered 'modest' in the pharmaceutical world.

Raptiva sales may be modest, but psoriasis sufferers number into the millions—4.5 million in the US. The skin condition, which correctly is a skin inflammation, has its roots in an individual's immune system. While there are several different kinds of psoriasis, the most common is plaque psoriasis, which forms as patches on the elbows, knees, lower back and scalp.

Plaque psoriasis, which is characterized by redness, dryness, the cracking of skin, bleeding and severe itch, can be unsightly and affects a whopping 80 percent of all psoriasis sufferers. Fingernails and toenails are often affected, and the condition can occur equally in men and women.

Little wonder that psoriasis sufferers so often seek some form of relief, given that psoriasis can affect the clothes you wear and even your career. Psoriasis can impact a job and ones' ability to earn a living. In this way, in can have a dramatic and negative affect on ones' livelihood.

Sometimes psoriasis can be hidden, but not all the time and often not effectively.

It was not revealed how many Raptiva prescriptions are in circulation. However, with 3 deaths and a potential fourth possibly linked to Raptiva, the FDA is signaling that those deaths are 4 too many, and will have to determine if the incidence of the rare PML condition, when compared against the total number of patients taking Raptiva, warrants removing the drug from the marketplace. The FDA uses benefit vs. risk as its benchmark criteria, and has been roundly criticized in the past for allowing dangerous, and often-lucrative drugs (lucrative for their manufacturers), on the marker too long.

Given the reportedly modest sales figures for Raptiva, it will be interesting to see what conclusions the FDA, and Raptiva manufacturer Genentech, ultimately come to.