FDA panel on anemia drugs has investors wary
Written on March 10, 2008
A U.S. Food and Drug Administration advisory panel may call on Thursday for further restrictions on the use of anemia drugs in cancer patients, leading some investors to expect lower sales for Amgen Inc’s (AMGN.O: Quote, Profile, Research) top-selling Aranesp.
Amgen shares have fallen about 20 percent since early December, largely over the risk of usage limits, and analysts say there is a chance the panel could take more drastic action and recommend anemia drugs not be used at all by many cancer patients.
“Most investors are not expecting this to go well,” said Eric Snyder, an analyst at Mehta Partners.
At a minimum, the panel of outside experts is expected to ask for a large-scale study to definitively measure safety.
The FDA a year ago put its strongest “black box” warning on the labels of Aranesp, as well as Amgen’s Epogen and Johnson & Johnson’s (JNJ.N: Quote, Profile, Research) Procrit, after studies showed a higher risk of death for some patients no fax payday loans.
The agency last week updated the warning to include information about studies showing that the drugs shortened survival for some cancer patients.
Over the past year, there has been a steady drumbeat of negative news about the drugs, which are genetically engineered versions of a protein that boosts production of oxygen-carrying red blood cells.
Concerns that the anemia drugs might be feeding tumor growth began to outweigh the perceived benefits of fewer blood transfusions and better quality of life for cancer patients.
Filed in: business.