Research & Development
US FDA grants priority review status to Novartis' crizanlizumab
18 July 2019 -

The United States Food and Drug Administration (FDA) has granted priority review status to Switzerland-based Novartis' humanised anti-P-selectin monoclonal antibody, crizanlizumab (SEG101), intended for the prevention of vaso-occlusive crises in patients with sickle cell disease, it was reported yesterday.

The company's application for the investigational drug is supported by results from a phase two trial, called SUSTAIN. In this mid-stage trial, the monoclonal antibody at 5mg/kg was indicated to have decreased the median annual rate of vaso-occlusive crises leading to health care visits by 45.3%, in comparison to placebo in patients with or without hydroxyurea. Also, clinically significant decrease were observed in the crizanlizumab arm in the frequency of vaso-occlusive crises among patients, irrespective of sickle cell disease genotype or hydroxyurea use in the SUSTAIN trial.

Novartis global drug development head and chief medical officer, John Tsai, said, 'The FDA's decision to give crizanlizumab priority review reflects the impact that this medicine could have for the many thousands of US sickle cell adult patients who experience painful vaso-occlusive crises. We are looking forward to the opportunity, if crizanlizumab is approved, to reimagine medicine in sickle cell disease for patients who live with this condition every day of their lives.'