> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts Novartis BLA for Sickel Cell Events
- URL: https://www.fdaweb.com/fda-accepts-novartis-bla-for-sickel-cell-events/
- Published: 2019-07-16T12:00:00.000Z
- Updated: 2026-09-15T01:38:00.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5144546

FDA has accepted for priority review a Novartis BLA for its investigational sickle cell drug crizanlizumab. The submission seeks approval for preventing vaso-occlusive crises (VOCs) in patients with sickle cell disease. Novartis says that VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic life-threatening complications and death.

The submission is supported by data from the Phase 2 SUSTAIN study, which showed that crizanlizumab (5 mg/kg) reduced the median annual rate of VOCs leading to health care visits by 45.3% compared with placebo. Data also demonstrated that the therapy showed a three-fold longer median time to first VOC vs placebo and a 42% reduction in median annual rate of days hospitalized vs placebo.