Posted by Michael Wonder on 16 Jul 2019
FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab
16 July 2019 - FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises in patients with sickle cell disease, shortening FDA review to six months from standard ten months.
Novartis today announced the US FDA accepted the company's biologics license application and has granted priority review for its investigational sickle cell medicine crizanlizumab (SEG101). If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease.
The FDA submission is supported by Phase II results from the SUSTAIN study, which showed that crizanlizumab (5 mg/kg) reduced the median annual rate of vaso-occlusive crises leading to health care visits by 45.3% compared with placebo (1.63 vs 2.98, P=0.010) in patients with or without hydroxyurea. Clinically significant reductions in the frequency of VOCs were observed among patients regardless of sickle cell disease genotype or hydroxyurea use.
