January 8, 2019 / 6:26 AM / 11 days ago

BRIEF-Novartis Receives FDA Breakthrough Therapy Designation For Sickle Cell Disease

Jan 8 (Reuters) - Novartis AG:

* NOVARTIS INVESTIGATIONAL THERAPY CRIZANLIZUMAB (SEG101) RECEIVES FDA BREAKTHROUGH THERAPY DESIGNATION FOR THE PREVENTION OF VASO-OCCLUSIVE CRISES IN SICKLE CELL DISEASE

* CRIZANLIZUMAB IS A MONTHLY INFUSION UNDER DEVELOPMENT TO PREVENT PAIN CRISES (ALSO CALLED VASO-OCCLUSIVE CRISES, OR VOCS) IN PATIENTS WITH SICKLE CELL DISEASE

* SICKLE CELL VOCS, WHICH ARE TRIGGERED BY MULTI-CELL ADHESION OR CLUSTERS OF CELLS THAT BLOCK OR REDUCE BLOOD FLOW, ARE ASSOCIATED WITH INCREASED MORBIDITY AND MORTALITY

* FDA GRANTED BREAKTHROUGH THERAPY DESIGNATION FOR CRIZANLIZUMAB BASED ON POSITIVE RESULTS OF PHASE II SUSTAIN TRIAL

* FDA FILING OF CRIZANLIZUMAB ANTICIPATED IN FIRST HALF OF 2019 Source text for Eikon: Further company coverage: (Reporting by Riham Alkousaa)

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