EMEA: Raptiva PML risks outweigh benefits

Sobering news on Genentech's psoriasis med Raptiva: Another case of the rare brain disease PML (progressive multifocal leukocephalopathy) has cropped up in a patient using the drug, marketed in Europe by Merck Serono. In announcing this case--the third confirmed diagnosis reported in recent months--the EMEA recommended suspending the drug in the E.U., saying its benefits no longer outweigh the risks.

The FDA didn't go so far. In October, when a previous PML case was announced, the agency added a "black box" warning to Raptiva's label; this time around, the FDA cautioned patients and doctors to be on the lookout for PML symptoms. For its part, Genentech said it's on the job; "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," company spokeswoman Tara Cooper told the Associated Press.

As you know, PML has dogged several drugs. Despite its overall rarity, the infection has arisen repeatedly in patients using the Biogen Idec/Elan multiple sclerosis treatment Tysabri and the Genentech/Biogen Idec arthritis med Rituxan.

- view the EMEA release
- read the RTT story
- see the article from the AP
- check out the Wall Street Journal coverage