Genentech Psoriasis Drug Raptiva PULLED

Raptiva is being withdrawn from the U.S. market, California-based drug maker Genentech announced Wednesday.

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

2,000 patients in the United States may currently be using Raptiva for chronic psoriasis. Since it was approved by the U.S. FDA in 2003, 46,000 patients worldwide have been treated with Raptiva, the Genentech said.

In February, an FDA advisory cited three deaths in people taking Raptiva. Two involved people with progressive multifocal leukoencephalopathy (PML). The third death was a person believed to have contracted the brain infection. All had been treated with Raptiva for at least three years, and none was taking other immune suppressants, which would make the body more susceptible to such infections.

Raptiva works by affecting T-cells in the immune system. The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections. Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003.

According to the FDA; there were no cases of PML seen in the clinical trials that supported the approval of Raptiva. At the time of approval, a total of 2,764 patients had been treated with Raptiva. Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML.

So there was a boxed warning of potential death with Raptiva, yet they continued to sell it because the risks at the time did not outweigh the benefits of the treatment of psoriasis. While Genentech is protecting patients (and ultimately is reputation, but not so much its wallet), those who have severe psoriasis are likely NOT going to want to stop taking the medication, even if they are risking serious infection.