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FDA grants priority review to Promacta for frontline treatment of severe aplastic anemia
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The FDA granted priority review designation to eltrombopag in combination with standard immunosuppressive therapy for the first-line treatment of severe aplastic anemia, according to the manufacturer.
Eltrombopag (Promacta, Novartis) — an oral thrombopoietin receptor agonist — is indicated for the treatment of adults and children with refractory severe aplastic anemia who have had an insufficient response to immunosuppressive therapy and patients with chronic immune thrombocytopenia who are refractory to other treatments, as well as for thrombocytopenia among patients with chronic hepatitis C virus infection.
The FDA based this priority review designation for first-line therapy on a study of treatment-naive patients with severe aplastic anemia. Results showed 52% of patients treated with eltrombopag plus immunosuppressive therapy achieved complete response at 6 months, an increase of 35% compared with patients treated with immunosuppressive therapy alone. The overall response rate at 6 months was 85%.
“Promacta is a great example of our drive to develop innovative treatments in serious disease areas where few treatment options exist,” Samit Hirawat, MD, head of global drug development at Novartis Oncology, said in a press release. “Thanks to the many individuals and organizations who have helped us to advance the development of this promising medicine. We will continue our work with the FDA to make Promacta available for this potential new indication as quickly as possible.”