Roche anemia drug approval delayed

The FDA has issued an approvable letter for Mircera for the treatment of anemia associated with chronic renal failure, and Roche expects the label to be finalized after the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has issued its recommendations on the entire class of erythropoiesis- stimulating agents (ESAs).

The committee plans to meet in the fall to discuss recommendations for the entire class of ESAs, following recent safety concerns raised over the therapies. The FDA has requested a black box warning for the drugs, which include Amgen’s blockbusters Aranesp and Epogen. ESAs are approved to treat anemia in patients with chronic kidney failure, and in cancer patients with anemia caused by chemotherapy.

George Abercrombie, president and CEO, Hoffmann-La Roche, said: “Ultimately, this class review provides the opportunity for Roche to launch Mircera into an environment where physicians and patients will have greater clarity on how to use these treatments. Roche will continue to work with the FDA following this meeting in order to expedite the conclusion of the review process.”