FDA issues Refusal to File Letter for ozanimod a proposed treatment for multiple sclerosis.- Clegene.
Celgene Corporation announced that it has received a Refusal to File letter from the FDA regarding its drug Application (NDA) for ozanimod in development for the treatment of patients with relapsing forms of multiple sclerosis.
Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator. Upon its preliminary review, the FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. Celgene intends to seek immediate guidance, including requesting a Type A meeting with the FDA , to ascertain what additional information will be required to resubmit the NDA.
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