Celgene Files NDA for Ozanimod to the US FDA for Relapsing Forms of Multiple Sclerosis (RMS)

 Celgene Files NDA for Ozanimod to the US FDA for Relapsing Forms of Multiple Sclerosis (RMS)

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

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