Raptiva risks outweigh benefits, E.U. regulators say

2/23/2009

NEW YORK More bad news about a Genentech drug for treating psoriasis emerged Friday, this time from Europe.

The European Medicines Agency said that the risks of Raptiva (efalizumab) outweigh the benefits, and the agency has recommended that marketing of the drug be suspended in the European Union after a patient developed progressive multifocal leukoencephalopathy, or PML, a deadly brain infection.

The U.S. Food and Drug Administration had released a statement Thursday saying that three people taking Raptiva over the course of several years had developed PML and died, but did not recommend removing it from the market.

PML results from an opportunistic infection by the JC virus, causing irreversible decline in brain function and death in people with severely weakened immune systems. According to the National Institutes of Health, most people carry the JC virus, though it is harmless to those with healthy immune systems. Raptiva works by suppressing the immune system's T-cells.

Merck Serono, a subsidiary of Germany-based Merck KGaA and a distinct company from U.S.-based Merck & Co., markets Raptiva in Europe.

X
This ad will auto-close in 10 seconds