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

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

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

Click here read full press release/ article | Ref: Celgene  | Image:  The Street

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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