Novaral's sickle cell drug gets FDA priority review

the U.S. Food and Drug Administration (FDA) has given Novarma's research sickle cell drug crizanlizumab (SEG101) priority review.
The regulatory agency accepted the company's Biologics Licensing Application (BLA) for the prevention of vascular ococcytosis (VOCs) in patients with sickle cell disease (SCD) and was awarded a breakthrough treatment designation in December 2018.
The submission was supported by the second phase of the SUSTAIN study, which showed that crizanlizumab (5 mg / kg) led to a 45.3% reduction in the mid-year VOC rate for health care visits compared to placebo.
FDA grants priority reviews to identify treatments that are likely to improve significantly in the treatment, diagnosis or prevention of serious diseases. The designation is intended to reduce the FDA's ten-month review period to six months.
“ The FDA's decision to give crizanlizumab priority review reflects the impact the drug may have on painful vascular ocular arrogance in thousands of adult patients with sickle cells in the United States," said John Tsai, Novarma's chief medical officer for global drug development and development.
if crizanlizumab is approved, we look forward to the opportunity to reimagine the drug for patients who live with sickle cell disease every day," he continued. "
sickle cell disease is a debilitating genetic blood disease that affects the shape of red blood cells and makes blood cells and blood vessels more viscous than usual.
when blood cells adhere to each other, they can form multicellular adhesion clusters in the blood stream. These clusters can reduce and block the flow of blood and oxygen, which can lead to vascular damage and lead to acute and chronic complications. （
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