Novartis announced Tuesday that the FDA granted priority review to an application seeking approval of crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD). The company noted that if authorised, the drug, also known as SEG101, will be the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in SCD.
John Tsai, head of global drug development at Novartis, remarked "the FDA's decision…reflects the impact that this medicine could have for the many thousands of US sickle cell adult patients who experience painful vaso-occlusive crises." In January, the company announced that the FDA granted crizanlizumab breakthrough therapy designation for the prevention of VOCs in patients of all genotypes with SCD.
Novartis indicated that the marketing submission is supported by data from the Phase II SUSTAIN study, which showed that crizanlizumab reduced the median annual rate of VOCs leading to health care visits by 45.3% compared with placebo in patients with or without hydroxyurea. Meanwhile, a post-hoc analysis of the trial demonstrated that 35.8% of crizanlizumab-treated patients did not experience a VOC, compared with 16.9% for placebo.
Along with the SUSTAIN study, there are a number of other trials in Novartis' SENTRY programme for crizanlizumab, including the Phase III STAND study investigating the drug in SCD patients aged 12 and above.
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