FDA fast tracks review of Novartis’ sickle cell disease tested drug

Novartis said Tuesday that the USFDA marked its investigational sickle cell drug crizanlizumab for Priority Review, which could be the first monoclonal antibody targeting the P-selectin mediated multi-cellular adhesion in sickle cell disease.

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

VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic life-threatening complications and death. VOCs also lead to significant health care utilization. They are the most common cause of emergency room visits and hospital admissions for SCD patients, with total medical costs exceeding $1.1 billion annually in the United States.

According to John Tsai, Head of Global Drug Development and Chief Medical Officer, Novartis the FDA’s decision to give crizanlizumab priority review reflects the impact that this medicine could have for the many thousands of US sickle cell adult patients who experience painful vaso-occlusive crises. He said: “We are looking forward to the opportunity, if crizanlizumab is approved, to reimagine medicine in sickle cell disease for patients who live with this condition every day of their lives.”