DARMSTADT, Germany, and ROCKVILLE, Maryland—Efalizumab (Raptiva^®, Genentech and Merck Serono) has been pulled from the market by the European Medicines Agency (EMEA) and is under review by the US Food and Drug Administration (FDA). Raptiva had been approved for treatment of difficult-to-treat plaque psoriasis.

The EMEA statement said, “The benefits of Raptiva no longer outweigh its risks, because of safety concerns... Prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives.”

The FDA warning included 3 confirmed and 1 possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in Raptiva patients, all of whom had taken the drug for more than 3 years. Three of the patients died.

According to the official FDA statement, “The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits; that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and that health care professionals carefully monitor patients for the possible development of PML.”

PML is caused by a virus that affects the central nervous system, usually occurs in people whose immune systems have been severely weakened, and leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.

Genentech spokesperson Tara Cooper told Musculoskeletal Report, “We take the risk of PML very seriously and are working diligently with the FDA to put the right plans in place that will help protect patient safety. We are evaluating all possible approaches to address the risk of PML with Raptiva use including a risk minimization plan. It is premature to disclose the scope of our plans until we’ve reached a formal agreement on these plans with the FDA.”

To read the FDA’s 2009 Public Health Advisory, go to: http://www.fda.gov/cder/drug/advisory/efalizumab.htm