Celgene announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for ozanimod for the treatment of relapsing forms of multiple sclerosis in adults.

Ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator, works by binding with high affinity selectively to S1P subtypes 1 and 5. Its mechanism may involve the reduction of lymphocyte migration into the central nervous system. The NDA submission included data from the phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled SUNBEAM and RADIANCE Part B trials.

SUNBEAM (N=1346) evaluated ozanimod 0.5mg and 1mg vs weekly intramuscular interferon beta-1a (Avonex; Biogen) for at least a 12-month period. The primary endpoint was annualized relapse rates (ARR) during the treatment period. The data showed a significant reduction in ARR for ozanimod 0.5mg (P =0.0013) and 1mg (P<0.0001) vs. interferon beta-1a over an average treatment duration of 13.6 months.

RADIANCE Part B (N=1320) also evaluated ozanimod 0.5mg and 1mg vs interferon beta-1a over 24 months. Both ozanimod doses showed statistically significance and clinically meaningful reductions in ARR over 24 months (primary endpoint).

“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, MD, 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.”

For more information visit Celgene.com.

