FDA delays approval of Roche’s anemia drug

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WASHINGTON—The U.S. Food and Drug Administration delayed a decision on the approval of Roche’s anemia drug Mircera amid increased scrutiny of the safety of erythropoiesis-stimulating agents (ESAs).

The FDA delay was announced May 18, but three days later Roche said the agency issued an “approvable letter” for Mircera for anemia treatment in chronic kidney disease patient on dialysis and not on dialysis. That means the drug could be approved if certain conditions and questions were addressed. Roche did not elaborate on the specifics.

Mircera differs from existing ESAs, such as Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit, in that it is designed to be given in longer-lasting monthly doses rather than weekly doses.

“Today’s announcement is good news for us as it confirms our confidence in Mircera,” William Burns, CEO of Roche’s pharmaceutical division, said in a statement. “We expect no further clinical trials being required prior to approval.”

On March 9, the FDA issued a public health advisory that outlined new safety information, which included updated product labeling for ESAs. The FDA pointed to recent studies with ESAs that have shown a higher chance of serious and life-threatening side effects and a greater number of deaths in patients treated with ESAs.

Several recent studies have shown ESAs can have adverse effects in treating cancer patients on chemotherapy by causing heart problems, blood clots and making the cancer worse. That prompted an FDA advisory committee to recommended new restrictions in treating anemia from chemotherapy. A similar panel is expected to meet in the fall to discuss the drug’s application in patients with kidney disease.

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