Faced with a variety of new studies that suggest that blockbuster anemia drugs raise the risk of death or make patients' cancer worse, an FDA advisory panel has voted to restrict the use of the drugs, demand new safety data and bar their use after chemotherapy is finished. The members also recommended that the use of the anemia drugs--Amgen's Aranesp and J&J's Procrit--be barred from some cancers, with suggestions to include breast, non-small cell lung and head and neck cancers. The panel voted against lowering the ceiling on the level of anemia correction. The FDA is not bound by the panel recommendations but typically follow their decisions.
The action marks yet another blow against biotech giant Amgen, which relies on anemia drugs to provide half of its $14.3 billion in annual revenue. And investors recognized just how serious the situation is, knocking down Amgen's stock price by nine percent following the voting.
- read the article from The New York Times