The U.S. Food and Drug Administration on May 18th again delayed action on approval of biologic drug Mircera, a genetically engineered protein for treatment of anemia in chronic kidney disease patients.

A spokesperson for Swiss drugmaker Roche said the FDA gave the company a draft of the drug's labeling, but said final FDA action was not expected before an agency advisory panel meets in the fall to discuss concerns over the safety and potential overuse of this class of anemia drugs in kidney patients.

A similar panel of cancer experts reviewed the use of the drugs in oncology patients this month, and made several recommendations that would restrict the potential use of Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit.

"We are confident that Mircera will be approved in the United States and we understand and support the FDA's initiative to convene an advisory panel to review the use of anemia agents in the renal setting," George Abercrombie, chief executive of Roche's Hoffmann-La Roche unit, said in a statement.

A Roche spokesperson said no additional studies will be required before Mircera can go on the market.

"Roche will continue to work with the FDA following this meeting in order to expedite the conclusion of the review process," Abercrombie added.

Roche is seeking approval of Mircera for treatment of anemia associated with chronic kidney disease in patients both on and not on dialysis.

Mircera is said by Roche to be the first biologic able to to correct anemia in chronic kidney disease patients with dosing once every two weeks and the first to maintain these patients on dosing intervals up to once a month.

This was the second time that FDA action on Mircera was postponed. Roche announced on Dec. 15th it had submitted more data to the FDA in support its application for the biologic, and said as a result, the deadline for an FDA decision had been extended three months.