FDA Accelerates Review Of Sickle Cell Disease Medicine Crizanlizumab

Novartis announced earlier today the FDA accepted the company’s Biologics License Application (BLA) and has granted Priority Review for its investigational Sickle Cell (SCD) medicine Crizanlizumab.

If FDA-approved, crizanlizumab is expected to represent the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease!

Novartis submitted the application for crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients with the disease and was granted Breakthrough Therapy designation in December 2018.

“We are looking forward to the opportunity, if Crizanlizumab is approved, to reimagine medicine inSCD for patients who live with this condition every day of their lives.”, stated Mr.John Tsai, MD, Head of Global Drug Development and Chief Medical Officer of the company.

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