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Novartis’ Sickle Cell Med Nabs FDA Priority Review

July 22, 2019

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.

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