Psoriasis drug to be pulled from market by June

WILMINGTON, Del. A biotech drug for psoriasis will be removed from the market amid concerns about the risk of brain infections.

Genentech and the Food and Drug Administration said Wednesday that they notified healthcare professionals of the voluntary, phased withdrawal of Raptiva (efalizumab) due to the risk of patients developing progressive multifocal leukoencephalopathy, a deadly brain infection caused by the JC virus. By June 8, the drug no longer will be available in the United States, and healthcare professionals have been asked not to prescribe the drug for any new patients.

In February, the FDA and regulators in the European Union declared that the risks of Raptiva outweigh its benefits. The European Medicines Agency recommended that the marketing of Raptiva be suspended, though the FDA did not take any similar action at the time.

The JC virus is present in most people, but harmless to those with healthy immune systems. Because Raptiva works by suppressing the immune system’s T-cells, this can cause the virus to infect the brain, causing irreversible decline in brain function and death. PML often occurs in people with severely suppressed immune systems, such as AIDS patients.

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