Swiss drugmaker Roche would have breathed a sigh of relief after it was announced this morning that its anaemia drug Mircera has taken a big step towards approval in Europe.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the erythropoiesis-stimulating agent Mircera be awarded clearance for the treatment of anaemia associated with chronic kidney disease.
If the drug makes it to market then its unique dosing schedule could give it a competitive edge over other ESAs in use. Mircera will likely be administered as a single injection every two weeks in patients not being treated with an ESA, or once a month to help maintain target haemoglobin levels in those already on such therapy, while rivals such as Amgen’s Epogen (epoetin alfa) and Johnson & Johnson’s Procrit (epoetin alfa) can be dosed up to three times a week.
“Mircera has been designed to overcome the shortcomings of currently used ESAs. It has been shown to provide stable maintenance of haemoglobin with only 12 injections a year, which may allow overworked renal units to devote more time to other patient needs,” Roche said.
US amber light
The company’s relief at the CHMPs backing would have been magnified by the fact that, just a few days ago, US regulators issued an amber light for the drug, amid fears about the safety of ESAs. The nature of the additional information the Food and Drug Administration requested in its approvable letter has been kept under tight wraps, but the Roche has said it will not involve conducting any further clinical trials, and that it is confident that Mircera gain full approval.
The FDAs letter came in the wake of an oncology advisory committee recommendation to further strengthening the warning labels on Aranesp (darbepoetin alfa), Epogen and Procrit. The new boxed warnings advise physicians to monitor red blood cell levels and to adjust the ESA dose to maintain the lowest haemoglobin level needed to avoid the need for blood transfusions, and physicians and patients are being asked to carefully weigh the risks of these products against transfusion risks.
A second panel is expected to meet in the next few months to review ESAs (but not Procrit) for patients with kidney disease.