Roche anemia drug approval is delayed
In good news for rival Amgen, the drug maker says the FDA won’t clear Mircera before a safety review this fall.
washington — Swiss drug maker Hoffman-La Roche Inc. said Friday that federal regulators stopped short of approving its anemia drug that would compete against blockbuster treatments from Amgen Inc. and Johnson & Johnson.
The delay is good news for investors of biotech giant Amgen Inc., whose stock dropped more than 15% in the last week because of safety concerns over its drugs Aranesp and Epogen. They account for nearly half of the Thousand Oaks-based company’s annual sales.
Roche, which has U.S. headquarters in Nutley, N.J., is seeking approval to market a treatment called Mircera in patients whose anemia is caused by chronic kidney disease.
Although a company spokeswoman said the Food and Drug Administration gave Roche a draft of the drug’s labeling, final approval won’t be given until after the agency’s meeting in the fall on the safety of anemia drugs in patients with kidney disease.
“Roche will continue to work with the FDA following this meeting in order to expedite the conclusion of the review process,” said George Abercrombie, Roche chief executive.
If approved, Mircera would have a major advantage over competitors: It is given in longerlasting monthly doses, compared with weekly doses for similar drugs from Amgen and Johnson & Johnson.
That could help dialysis center operators, such as El Segundo-based DaVita Inc., reduce the treatment costs for kidney disease patients.
Last week, an FDA panel recommended that warning labels be added to anemia drugs when they are used by cancer patients, two months after regulators ordered that anemia drug labels warn of the risks of blood clots, heart attack or death when taken at high doses. The labels apply to Amgen’s two drugs and Johnson & Johnson’s Procrit.
Shares of Amgen rose 71 cents in after-hours trading to $54.75 after ending the regular trading session up 36 cents to $54.04.