Crizanlizumab


Crizanlizumab,, is a monoclonal antibody developed by Novartis targeted towards P-selectin. It was announced by the company as an effective drug to prevent vaso-occlusive crisis in patients with sickle cell anemia. The result of the Phase II SUSTAIN clinical trial was published in December 2016.
Crizanlizumab is a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for those 16 years and older.
In November 2019, crizanlizumab-tmca was approved in the United States.

Pathophysiology

molecules are present on the surface of vascular endothelial cells and have been linked to sickle cell vaso-occlusive crises.

History

The U.S. Food and Drug Administration approved crizanlizumab based on evidence from one clinical trial of 132 patients with sickle cell diseases who had a history of vaso-occlusive crisis. The trial was conducted at 60 sites in the United States, Brazil and Jamaica.
The FDA granted the application for crizanlizumab-tmca priority review, breakthrough therapy designation, and orphan drug designation. The FDA granted approval of Adakveo to Novartis.