Celgene has been dealt a heavy blow, revealing that the FDA has rejected its New Drug Application for its sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator ozanimod in the treatment of relapsing forms of multiple sclerosis.
The US regulator refused the application in a ‘refusal to file’ letter on the basis that its nonclinical and clinical pharmacology sections were insufficient. Celgene said it will seek immediate guidance on the decision to determine exactly what extra information is needed to secure a complete review.
