Anemia Drugs Under FDA Scrutiny Again

UPDATE FRIDAY, 3-14-08: * NEW:

On Thursday the companies that make anemia drugs for cancer patients dodged a bullet.

An FDA advisory panel called for additional restrictions on the drugs, but did not vote to remove them from the marketplace as Amgen, maker of Aranesp and Johnson & Johnson, maker of Procrit had feared. 

The FDA panel had difficulty pulling the drugs because the eight trials they were considering, which showed an increase in tumor growth, also involved higher doses of the drugs than would typically be given.

The move saves the drug makers about a $1 billion in revenue. 

Most of the anemia drugs are for more advanced stages of cancer and the committee voted 11 to 2 that people in the early stages of cancer not take the anemia drugs hoping to cure their cancer.   

Upon the news, Amgen shares rose nearly five percent. J & J closed up 26 cents.

THURSDAYS STORY CONTINUES HERE:  

Two major drug companies will go before a critical FDA panel today to defend the benefit of their multi-billion dollar anemia drugs used by cancer patients undergoing chemotherapy.

The FDA is considering whether to revoke the approval of the drugs because of concerns that  – Amgen’s Aranesp and Johnson & Johnson’s Procrit may cause tumors to grow and ultimately shorten the life of patients.

Evidence is mounting against use of the drugs as the panel will look at eight clinical trials that suggest tumors progress and the drugs do not contribute to the quality of life of patients.

The companies insist that the benefits outweigh the risks because they reduce the need for blood transfusions to treat anemia in cancer patients.  The medications are also used by those with kidney disease.

The genetically engineered drugs known as ESAs or erythropoiesis-stimulating agents, increase red blood cells needed to fortify the patient's blood. 

Already the anemia drugs have received a stronger “black box” warning to their label encouraging the lowest possible doses to avoid blood clots, heart attacks, stroke, and tumor growth and an increased risk of death. 

Procrit, approved in 1989 used to say it improved the quality of life among patients with anemia, but since then Procrit has been forced to undergo five label changes which now says there was no evidence to back that claim.

Last November the FDA issued a public health advisory on ESAs. 

The expert panel will decide soon whether to recommend to the FDA whether to further restrict the label warnings or to have cancer patients sign a consent form before beginning ESAs. The FDA usually follows an expert panel’s advice.

Fears are that sales could drop more for Aranesp, which last year brought Amgen $3.6 billion. Procrit’s sales last year at $2.9 billion represented a nine percent slide.   #