Celgene Reports FDA and EMA’s Acceptance of NDA for Ozanimod to Treat Relapsing Forms of Multiple Sclerosis

Celgene Reports FDA and EMA’s Acceptance of NDA for Ozanimod to Treat Relapsing Forms of Multiple Sclerosis

Shots:

  • The acceptance of NDA is based on P-III SUNBEAM and RADIANCE Part B study results assessing oral ozanimod (0.92/0.46 mg) in 1,346 & 1,320 patients with RMS across 152 & 150 sites in 20 & 21 countries respectively
  • The US FDA and EMA accepted the NDA for ozanimod to treat relapsing forms of multiple sclerosis (RMS) and relapsing-remitting multiple sclerosis (RRMS) with its expected PDUFA date as Mar 25, 2020 and H1’20 respectively
  • Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor modulator used for binding to S1P subtypes 1 (S1P1) and 5 (S1P5) and is targeted for immune-inflammatory indications including RMS, ulcerative colitis and Crohn’s disease

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