EU Tightens Guidelines On Anemia Drugs
Make a commentBy Ed Silverman // September 27th, 2007 // 1:40 pm
The crisis continues for Amgen ceo Kevin Sharer. Now, the European Medicines Agency, or EMEA, is proposing special warnings and reduced dosing recommendations for Amgen’s top-selling Aranesp and Epogen, as well as Johnson & Johnson’s Procrit (or Eprex). New prescribing info may say studies show more deaths associated with increased dosing of anemia meds and that the drugs haven’t been shown to improve overall survival in cancer patients with anemia.
An EMEA panel recommends that anemia drugs be given to boost hemoglobin levels to 10 to 12 grams per deciliter of blood, according to an Amgen statement. Previously guidance ranged from 11 to 14 grams, in kidney failure patients; the ceiling was 13 for cancer patients. Earlier this month, an FDA panel voted to keep the maximum dosing at 12 grams and not lower the threshhold to 11 grams.
The guidelines “could have been worse, but (is) still a negative,” writes Jim Reddoch, an analyst at Friedman Billings Ramsey, in an investor note this afternoon. He goes on to add that the outlook for Amgen is dimming, given that Medicare recently cut reimbursement. “We think it continues to get worse for Aranesp as the full effect will likely be realized in (the fourth quarter) as the decision did not go into effect until the end of July (and accounts may have had standing orders before then.”
In the US, prescribing info for Aranesp advises using the lowest dose to achieve hemoglobin targets, and warns the anemia meds increase the risk of death and heart complications when hemoglobin levels greater than 12 grams are reached. The National Kidney Foundation recommends the drugs be given to increase hemoglobin to a maximum of 12 grams a deciliter, the level approved by the FDA.