May 21, 2007
FDA delay on Mircera a reprieve for Amgen, J&J
The FDA delayed an approval decision on Roche’s Mircera pending a fall advisory committee review, spelling temporary relief for marketers of similar biologics.
Mircera, an experimental treatment for anemia associated with chronic renal failure, is expected to compete with Amgen’s Aranesp and Epogen.
Roche said the FDA appeared satisfied with its Mircera label but stayed a decision until after the fall advisory committee meeting, at which the safety of anemia drugs in patients with kidney disease will be discussed.
Safety concerns have plagued the entire class of so-called erythropoiesis stimulating agents. This month An FDA panel recommended adding additional warning labels to the drugs when they are used by cancer patients. Two months ago, regulators said anemia drug labels must contain a black-box warning of the risks of blood clots, heart attack or death when taken at high doses.
Mircera, if approved, would be the only long-acting anemia drug available, giving it an advantage over the Amgen offerings. Amgen’s two drugs, as well as Johnson & Johnson’s Procrit, are also used to treat anemia caused by chemotherapy.