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

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

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

Click here to read full press release/ article | Ref: Novartis | Image: Novartis

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

Related post