FDA panel seeks curbs on Amgen, J&J anaemia drugs

The US food and Drug Administration (FDA) has demanded that Amgen Inc. and Johnson & Johnson put new restrictions in prescribing information for their top-selling anemia drugs.

Amgen and Johnson & Johnson should further strengthen the warning labels of their blockbuster anemia drugs and conduct additional studies to prove their safety, an FDA advisory committee has recommended.

The committee voted 15-2 in favor of additional restrictions to the drugs'' labels for further marketing authorisation of the drugs. It also unanimously recommended additional clinical studies on the drugs, an FDA spokesperson said.

The FDA panel examined studies that showed the drugs - Aranesp and its earlier, shorter-acting version, Epogen - raised the risk of heart attacks, strokes and death when used at high doses.

The medicines accounted for $6.6 billion, or 47 per cent, of Amgen''s revenue in 2006.

The FDA had warned doctors in March to use the lowest possible doses, and new limits could reduce the company''s sales of the drugs by as much as 17 per cent, an analyst said.

Amgen had licensed several rights for Epogen to Johnson & Johnson in the 1980s, which had since marketed it under the name Procrit. The injectable drugs are known as erythropoiesis-stimulating agents, or ESAs, and act by stimulating the production of red blood cells in the body.

ESAs are approved to treat chemotherapy-induced anemia and chronic kidney disease-related anemia.

Meanwhile, another agency committee will meet to discuss the safety profile of the drugs in relation to kidney patients in early fall, the spokesperson said.

Shares of Amgen fell $5.77, or 9.1 per cent, to $57.33 at 4 p.m. in Nasdaq Stock Market composite trading, the biggest drop in more than five years. J&J shares fell $1.61, or 2.5 per cent, to $62.50 on the New York Stock Exchange.