FDA to Review Promacta for First-Line Treatment of Severe Aplastic Anemia
The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Promacta (eltrombopag; Novartis) in combination with standard immunosuppressive therapy (IST) as first-line treatment of severe aplastic anemia (SAA). The treatment has also been granted Priority Review designation.
The FDA decision to grant Priority Review was based on results from a National Institute of Health (NIH) study which demonstrated a 52% complete response rate and an 85% overall response rate in treatment-naïve SAA patients treated with eltrombopag plus standard IST.
Promacta, an oral thrombopoietin receptor agonist (TPO-RA), is already approved to treat SAA in adults who have insufficient response to IST. It is also approved for the treatment of thrombocytopenia in adult and pediatric patients ≥1 year old with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy and for thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
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