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FDA to Refuse Celgene for Filling Ozanimod's NDA for the Treatment of Relapsing Multiple Sclerosis

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FDA to Refuse Celgene for Filling Ozanimod's NDA for the Treatment of Relapsing Multiple Sclerosis

 Shots:

     •  The rejection of Ozanimod was based on unmet preclinical and clinical trials results- in patients with relapsing multiple sclerosis

   •  Additionally- Celgene plans to resubmit NDA- with onset of Type A meeting with FDA regarding development of the product

   •  Ozanimod is an oral sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator indicated for inflammatory- relapsing multiple- sclerosis ulcerative colitis and Crohn's disease

Ref: Celgene  | Image:  The Street


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