More bad news for Amgen and J&J as US FDA reviews new data on ESA risks

In yet another piece of negative news for US drug major Johnson & Johnson and biotechnology giant Amgen, which could further limit the use of their anemia drugs (Marketletters passim), the Food and Drug Administration says it is reviewing new data from two studies that provide additional evidence of the risks of these products, known as erythropoiesis-stimulating agents, or ESAs.

The drugs in question are Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), which in 2006 generated revenues of some $6.6 billion for the firm but sales have fallen sharply since the safety concerns emerged early last year, and J&J's Procrit (epoetin alfa). Amgen's share price, already well down on this issue, fell a further 2% to $45.69 - a five-year low - on the January 3 FDA announcement, while J&J, much less dependant on its product, gained marginally to $65.93.

The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who did not receive the anemia drug.