The safety concerns recently raised about TNF blockers in general and Enbrel in particular weren't enough to keep the Amgen drug down. An FDA advisory panel voted 7-5 in favor of using Enbrel in children with moderate-to-severe psoriasis. As you know, it's already approved for use against rheumatoid arthritis in children and adults, and against psoriasis in adults. It pulled in $3.2 billion in 2007 revenues.
The vote follows an announcement earlier this week that the FDA aims to strengthen the warning labels on Enbrel. The agency wants to flag the risk of death among children and of moderate-to-severe infections in adults. That's because the agency found in its database a series of serious malignancies, infections, and neurological problems in pediatric patients who took Enbrel (a.k.a. etanercept).
Meanwhile, the agency is studying the entire class of drugs--the tumor necrosis factor blockers--for possible links to childhood cancers, especially lymphoma, in kids treated for RA or Crohn's disease. Enbrel is one of those drugs; the others approved in the U.S. are Humira (Abbott Laboratories), Remicade (Johnson & Johnson), and Cimzia (UCB).
- here's re release
- read the Washington Post story
- see the piece at CNN Money