Tags : crizanlizumab

Regulatory

Novartis’s SEG101(crizanlizumab) Receives FDA’s Breakthrough Therapy(BT) Designation for Sickle Cell

Shots: The BTD is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO in patients with/without hydroxyurea therapy for preventing vaso-occlusive crises(VOCs) in SCD P-II SUSTAIN study results: median annual rate (45.3%); patients not experiening VOCs (35.8% vs 16.9%); AE (86.4% vs 88.7%); serious AEs (25.8% vs 27.4%), with no increment in rate of […]Read More