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Friday, November 15, 2019

FDA OKs Novartis’ crizanlizumab for sickle cell disease

Under Priority Review status, the FDA approves Novartis’ (NVS +0.7%) Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in patients at least 16 years old with sickle cell disease (SCD).
Vaso-occlusive crisis is a painful complication of SCD that arises when microcirculation in obstructed by sickled red blood cells. It is the most common reason for emergency room visits and hospital admissions in these patients.
Crizanlizumab is a humanized monoclonal antibody that binds to a protein on the surface of platelets and endothelium in blood vessels called P-selectin which plays a key role in the vaso-occlusive process.

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