Celgene Files NDA for Ozanimod to the US FDA for Relapsing Forms of Multiple Sclerosis (RMS)
Shots:
- The NDA filing is based on P-III SUNBEAM & RADIANCE studies assessing Ozanimod vs Avonex in 1-346 & 1-320 patients with RMS across 21 countries for 12 & 24 mos. respectively
- In H1’19 Celegene has also filed MAA to EMA for relapsing-remitting multiple sclerosis in adults and plans to develop new therapies for RMS in 2020
- Ozanimod (0.92/0.46 mg) is an oral sphingosine 1-phosphate (S1P) receptor modulator and currently in development for other indications including RMS- ulcerative colitis and Crohn's disease
Ref: Celgene | Image: The Street
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