Novartis drug Promacta receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA)
- Data supporting designation showed over half of treatment-na?ve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of 85%[1]
- Promacta is the only TPO receptor agonist indicated for the treatment of patients with SAA, currently in the refractory setting
- Regulatory filings of the first-line indication in US and EU expected in 2018