FDA Delays Approval of Roche Anemia Drug
Friday May 18, 7:09 pm ET
FDA Stops Short of Approving Roche Anemia Drug That Would Compete With Amgen and J&J Offerings
WASHINGTON (AP) -- Swiss drug maker Roche said Friday federal regulators stopped short of approving its anemia drug that would compete against blockbuster treatments from Amgen and Johnson & Johnson.
The delay is good news for investors of biotech giant Amgen Inc., whose stock dropped more than 15 percent in the last week due to safety concerns over treatments Aranesp and Epogen, which account for nearly half of annual sales.
Roche, which has its U.S. headquarters in Nutley, N.J., is seeking approval to market a comparable treatment called Mircera in patients whose anemia is caused by chronic kidney disease.
While a company spokeswoman said the Food and Drug Administration gave them 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, Hoffmann-La Roche Chief Executive.
If approved, Mircera would have one major advantage over competitors: it is given in longer-lasting monthly doses compared with weekly doses for similar drugs from Amgen and Johnson & Johnson. That could help dialysis center operators, such as DaVita Inc., reduce the costs of treatment for kidney disease patients.
Last week, an FDA panel of government advisers recommended that additional 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 J&J's Procit.
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 Friday. |
