FDA panel backs Amgen drug for blood disorder
GAITHERSBURG, Maryland (Reuters) - A U.S. advisory panel unanimously urged regulators Wednesday to approve an Amgen drug for a rare blood disorder that puts patients at risk of serious bleeding.
The Food and Drug Administration advisers said the benefits of the injectable drug, called Nplate, outweighed the risks for treating chronic immune thrombocytopenia purpura, or ITP.
The FDA will decide whether to approve Nplate but usually follows panel recommendations. Amgen said it expects a final ruling during the first half of 2008.
Before the panel vote, FDA reviewers had voiced concern about potential long-term risks of Nplate. Amgen said it would limit distribution and closely monitor side effects after approval.
Rodman & Renshaw analyst Michael King has estimated Nplate sales in 2009 of $117 million, which would make it a relatively small drug for giant biotech company Amgen. The company's 2007 revenue was $14.7 billion.
Amgen shares, which have been pressured by safety concerns surrounding its franchise of anemia drugs, rose 1.75 percent to $45.40 in afternoon trading on Nasdaq.