Novartis SEG101 (crizanlizumab) received priority review from US FDA
Novartis received priority review for crizanlizumab. Indicated for the treatment of sickle cell disease. FDA granted the review based on the Phase 2 data, demonstrating the efficacy of crizanlizumab in preventing the vaso-occlusive crises (VOCs). The approval helps in shortening the FDA review from ten months to six months. VOCs causes extreme pain and can eventually lead to death.
The product is the first monoclonal antibody targeting P-selectin mediated multi-cellular adhesion.
The trial showed:
36% of patients on crizanlizumab showed no VOC events compared to 17% on placebo
The median time to fist VOC: 4.07 months vs 1.38 months
Median annual rate of hospitalization days: 42 % reduction compared to placebo
In December 2018, the product received the breakthrough designation from the US FDA.