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