Novartis’ Sickle Cell Med Nabs FDA Priority Review
The FDA has granted Novartis’ investigational sickle cell disease treatment crizanlizumab (SEG101) priority review status.
Novartis submitted the crizanlizumab application for preventing vaso-occlusive crises (VOCs), unpredictable episodes of acute pain that are the disease’s most common complication.
The company’s submission is supported by Phase 2 trial results showing the treatment reduced the median yearly rate of VOCs that led to healthcare visits by 45.3 percent compared to a placebo.
The drug received a breakthrough therapy designation in December.