Policy & Regulation
Novartis receives breakthrough therapy designation for crizanlizumab from US Food and Drug Administration
10 January 2019 -

Switzerland-based Novartis has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for crizanlizumab (SEG101) in order to prevent vaso-occlusive crises in patients of all genotypes with sickle cell disease, it was reported yesterday.

The product is a humanised anti-P-selectin monoclonal antibody being studied to restrict vaso-occlusive crises in sickle cell disease.

The status has been offered based on positive data from the phase II Sustain study, which compared the P-selectin inhibitor crizanlizumab against placebo in patients with sickle cell disease. The study indicated that crizanlizumab decreased the median annual rate of vaso-occlusive crises leading to health care visits by 45.3% compared to placebo in patients with or without hydroxyurea therapy, according to the company. The sustain study also showed that crizanlizumab significantly increased the percentage of patients who did not experience any vaso-occlusive crises against placebo during treatment.

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