Amgen Inc. (AMGN), a biotechnology company based in Thousand Oaks, California, on Wednesday said the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee unanimously voted to recommend approval of the romiplostim application.
According to the company, the new application has the potential to be an important new treatment option for the orphan population of adult patients suffering from chronic immune thrombocytopenic purpura, an autoimmune disorder characterized by low platelet counts in the blood.
The company believes that the data contained in its registrational clinical studies paired with the proposed comprehensive risk management program support approval by the FDA in the second quarter of this year.
AMGN is currently trading at $45.38, up $0.76 or 1.70%, on 9.93 million shares.
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