NUTLEY, N.J.—A study in the October 20 issue of The Lancet showed that dialysis patients can be effectively switched from frequently dosed anemia drugs to Roche’s Mircera, which is given once a month to patients.
“Our findings demonstrate Mircera was administered up to once every four weeks in hemodialysis patients without sacrificing hemoglobin stability,” Nathan Levin, MD, the medical and research director of the Renal Research Institute, lead researcher of the study, said in a statement. “We note in The Lancet that these results should be generalizable to the maintenance hemodialysis population and that we believe this drug should be an option to epoetin for simplified anemia management.”
Researchers said the study was the first randomized, comparative study that looked into converting patients from erythropoiesis-stimulating agents given one to three times a week to Mircera, which was given to patients once every two weeks or once every four weeks.
The study followed a total of 673 dialysis patients with stable chronic renal anemia in nine centers in eight countries. Most of the patients, however, were from North America; 68 percent were from the United States, 11 percent were from Canada and 21 percent were from Europe
After 42 weeks, researchers found that there were no statistically significant differences in hemoglobin concentrations between patients taking ESAs more frequently when compared to Mircera.
The news of Mircera’s use in dialysis patients comes on the heels of its patent infringement case with Amgen going to jury deliberations. The judge in the U.S. District Court of Boston has already ruled that Mircera infringes on one of Amgen’s patents. However, in its closing arguments October 18, Roche said to the jury that Amgen is using invalid patents to stifle innovation and competition in the United States. As a result, the jury must decide whether or not Amgen’s patents are invalid, and if so, whether or not Mircera violates them.
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