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FDA Oncology Panel Recommends Approval for Romiplostim
"We are pleased that the panel today recognized the importance of this therapeutic advance and unanimously voted to recommend approval of the romiplostim application. We believe that this product has the potential to be an important new treatment option for the orphan population of adult patients suffering from chronic ITP. Patients with chronic ITP, a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia) face the risk of bleeding events due to low platelet counts.
"We look forward to continued productive discussions with the FDA. We strongly believe the data contained in our registrational clinical studies paired with the proposed comprehensive risk management program support approval by the FDA in the second quarter of this year."