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Mircera gains FDA approvable letter


The FDA has issued an approvable letter for Mircera® (continuouserythropoietin-receptor activator, CERA) for treating anaemiaassociated with chronic renal failure including patients on and not ondialysis, according to the drug’s manufacturer, Roche.

Thefirm has received a draft label from the FDA and expects this to befinalised after the FDA’s cardiovascular and renal drugs advisorycommittee has issued recommendations on the entire class oferythropoiesis-stimulating agents (ESAs).

The FDA willconvene the meeting to consider class topics related to ESAs in therenal setting. Roche and all other sponsors of ESAs in the USA havebeen informed of the planned committee meeting in the autumn, and it isunderstood that recommendations from this meeting could impact classlabelling for all ESAs.

Roche president and chief executiveofficer George Abercrombie said: “We are confident that Mircera will beapproved in the United States, and we understand and support the FDA’sinitiative to convene an advisory panel to review the use of anaemiaagents in the renal setting.”

The filing for Mircera isbased on what is claimed to be the largest initial registrationprogramme conducted in the renal anaemia arena, comprising 10 globalstudies and 2,700 patients from 29 countries.

Businesswire 21/5/07


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