What a difference a continent can make. A week ago, the FDA delayed approving Roche’s anemia med. But today, the EMA’s Committee for Medicinal Products for Human Use, says the drug should be used to treat anemia associated with chronic kidney disease.

Mircera will compete with Amgen’s Epogen and Aranesp medicines, although this group of meds is under intense scrutiny from doctors, lawmakers and federal officials since studies suggested the medicines increased heart risks at high doses.

“We anticipate a standard timeline for approval in Europe,” says Dan Kemmler, head of Roche’s anemia program. “Roche is very confident we’ll gain approval in the US and upon approval we will launch…We’ve got a very strong label. We see Mircera really taking market share.”

The FDA won’t clear Mircera until the agency’s Cardiovascular and Renal Drugs Advisory Committee issues new recommendations on the use of such treatments later this year.

Source: Bloomberg News[tags]Amgen, Mircera, Roche[/tags]