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

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 infection
• Crizanlizumab is a mAb anti-P-selectin indicated for the prevention of vaso-occlusive crisis (VOCs) in patienst with SCD with its expected NDA submission to FDA in H1’19

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