Novartis Reports FDA’s Acceptance of BLA for Crizanlizumab (SEG101) to Treat Sickle Cell Disease

 Novartis Reports FDA’s Acceptance of BLA for Crizanlizumab (SEG101) to Treat Sickle Cell Disease

Novartis Reports FDA’s Acceptance of BLA for Crizanlizumab (SEG101)

Shots:

  • The US FDA has accepted Novartis’ BLA and has granted Priority Review for crizanlizumab to prevent vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD)
  • The FDA submission is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO further resulting in a reduction in VOCs (36% vs 17%), m-time to first VOC (4.07 vs 1.38 mos.), 42% reduction in annual rates of hospitalization days
  • Crizanlizumab is a mAb targeting P-selectin mediated multicellular adhesion for the prevention of VOCs in patients with SCD, being evaluated in multiple studies for SCD in different age groups

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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