After a failed attempt in 2017, Celgene has decided to refile its relapsing remitting multiple sclerosis (RRMS) drug, ozanimod, with the US Food and Drug Administration (FDA).
Last February, Celgene received a “Refuse to File” notice from the FDA, after the governing body found issues in the submission's non-clinical and clinical pharmacology sections, claiming that they were not sufficient to allow a complete review.
The submission comes shortly after the company also submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) for adults with relapsing-remitting multiple sclerosis.
The applications are based on data from the SUNBEAM and RADIANCE Part B trials, as well as results from the former in 2017, showing that ozanimod was associated with significant improvements in annualised relapse rates versus Biogen's Avonex
“New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” said Jay Backstrom, M.D., chief medical officer for Celgene.
“With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in 2020.”
Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 and 5. It is also in development for immune-inflammatory indications including RMS, ulcerative colitis and Crohn's disease.