FDA OKs Mircera but ruling delays launch

Swiss drug major Roche says that the US Food and Drug Administration has approved its drug Mircera (methoxy polyethylene glycolspoetin beta) for the treatment of anemia associated with chronic renal failure. However, a recent ruling that the product infringes on patents held by US biotechnology major Amgen (Marketletter October 29), means that a launch in that country is unlikely in the near term.

Roche added that the FDA's approval decision, which clears Mircera as a treatment for adult CKD patients regardless of dialysis status, was based on data from 10 worldwide studies involving more than 2,700 participants. Results from the program showed that 97.5% of those treated with the drug who were not receiving any other erythropoieses-stimulating agent, achieved target hemoglobin levels on a twice monthly dosing regimen. In addition, subjects demonstrating Hb stability using shorter-acting more frequently administered drugs maintained their Hb levels when switched to Roche's product.

George Abercrombie, Roche's US chief executive, said he was pleased with the FDA's decision and added that the firm, which is considering all options regarding its defeat in the Amgen suit, is hopeful "that patients and health care providers in the USA will be able to have access to Mircera as soon as possible in a responsible and legal manner."