FDA to Review Promacta for First-Line Treatment of Severe Aplastic Anemia

Promacta is already approved to treat SAA for patients who have insufficient response to standard immunosuppressive therapy
Promacta is already approved to treat SAA for patients who have insufficient response to standard immunosuppressive therapy

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.   

Related Articles

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.

For more information visit Novartis.com.