Monday, May 14, 2007

FDA: Bad news for Aranesp

At the FDA last week the Oncology Drugs Advisory committee voted 15-2 to add additional restrictions to the Aranesp label and voted 12-5 to restrict certain tumor types from the drug's label. The panel was concerned about the lack of large, randomized trials of the EPO drugs and limited survival data. The FDA is not required to follow an advisory panel's advice, but it often does.

The committee voted 15-2 in favor of having further marketing authorization of the drugs be contingent upon adding additional restrictions to the drugs' labels. It also unanimously recommended further marketing of the drugs should be contingent on the companies conducting additional clinical studies.

These types of drugs are "injectables" known as erythropoiesis-stimulating agents, or ESAs, and act by stimulating the production of red blood cells in the body.

Story sources include: and the FDA site.