Bristol-Myers Squibb (BMS, NYSE: BMY) has announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its ozanimod, a novel selective sphingosine-1-phosphate (S1P) receptor modulator. The drug is now approved to treat recurrent multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis. This marks the US major’s first approval in the autoimmune disease treatment area in China.
Approval Based on Positive Clinical Data
The NMPA approval is based on the results of two large, positive Phase III studies: SUNBEAM (12 months) and RADIANCE (Part B, 24 months). These studies assessed the efficacy and safety of ozanimod, taken orally once per day, compared with AVONEX (recombinant human interferon β-1a, intramuscular injection, once a week). The results demonstrated that ozanimod provided significant clinical benefits over AVONEX.
Mechanism of Action
Ozanimod works by moderately inhibiting lymphocyte migration and reducing the number of lymphocytes in peripheral blood. While the exact mechanism of its therapeutic effect on multiple sclerosis is not fully understood, it is believed to be related to the reduction of lymphocyte migration to the central nervous system.
Global Approvals and Pipeline
Ozanimod is the world’s first S1P receptor modulator approved for both multiple sclerosis and ulcerative colitis (UC). It received US approvals for MS and UC in March 2020 and May 2021, respectively, and EU approvals in May 2020 and November 2021. Additionally, a global study for Crohn’s disease is currently underway.-Fineline Info & Tech
