FDA accepts new drug application for new kiozanimod for recurrent multiple sclerosis

recently, Celgene announced that the UsFDA(http://has accepted the application fornew drug
(http://(NDA) for the treatment of recurrent multiple sclerosis (RMS), and the EuropeanMedicines(http://Authority (EMA) has also accepted the marketing license application (MAA) for the treatment of recurrent recurrent multiple sclerosis (RRMS)About ozanimod
ozanimod is an oral 1-phosphate pyridoxanol (S1P) receptor regulator that can selectively bind to S1P subtype 1 (S1P1) and subtype 5 (S1P5) with high affinityUnder the Prescription Drug User Charges Act (PDUFA), the FDA will make a review decision on March 25, 2020The EMA is expected to make a review decision in the first half of 2020Ozanimod is the core asset of the $7.3 billion acquisition of Receptosin 2015(http:// On u.S regulatory issues, ozanimod was rejected by the FDA earlier in 2018 on the grounds that non-clinical and clinical pharmacological evidence was insufficient to permit review 　　The ndA and MAA are based on efficacy and safety data from 2 multicenter, randomized, double-blind, double-simulated, positive drug (http:// control Phase III clinical studies SUNBEAM and RADIANCE Part B 　　At the end of March this year, Novartis oral drug Mayzent (siponimod) was approved by the FDA for the treatment of adult patients with RMS, including active secondary progressive sclerosis (SPMS), recurrent recurrent multiple sclerosis (RRMS), and clinical isolation syndrome (CIS) Mayzent is the first and only therapeutic drug in the past 15 years specifically approved for patients with active SPMS, with the active ingredient siponimod, a new generation of selective 1-phosphate pyridoxinol (S1P) receptor regulators that selectively bind to S1P1 and S1P5 receptors and act in the same way as the new ozanimod