Bristol Myers Squibb Receives European Commission Approval for Zeposia (ozanimod) in Active Relapsing Remitting Multiple Sclerosis
Bristol-Myers Squibb
Biopharmaceutical and Nutritional Product R&D and Sales
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled by S. Li
On May 27, Bristol-Myers Squibb (BMS) announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with active relapsing-remitting multiple sclerosis (RRMS), as defined by clinical or imaging features.
Zeposia is an oral selective sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity and selectivity to S1P receptor subtypes 1 (S1P1) and 5 (S1P5). In March this year, Zeposia received approval from the U.S. FDA for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.
The approvals by the FDA and EC were both based on data from SUNBEAM and RADIANCE Part B, the largest head-to-head pivotal Phase 3 clinical trials conducted to date in patients with multiple sclerosis (MS). These two studies enrolled more than 2,600 patients across 150 sites in over 20 countries worldwide. Key findings from the trial results included:
In the SUNBEAM study, Zeposia reduced the annualized relapse rate (ARR) by 48% relatively within one year (ARR: 0.18 vs. 0.35); in the RADIANCE study, it reduced the annualized adjusted relapse rate (AAR) by 38% relatively over two years (AAR: 0.17 vs. 0.28);
In the SUNBEAM study, after one year of treatment, Zeposia reduced the number of T1-weighted gadolinium-enhancing (GdE) brain lesions by 63% relative to Avonex (0.16 vs. 0.43) and reduced the number of new or enlarging T2 lesions by 48% relative to Avonex (1.47 vs. 2.84);
In the RADIANCE study, after two years of treatment, Zeposia reduced the number of T1-weighted gadolinium-enhancing (GdE) brain lesions by 53% relative to Avonex (0.18 vs. 0.37) and reduced the number of new or enlarging T2 lesions by 42% relative to Avonex (1.84 vs. 3.18).
Compared with Avonex, Zeposia resulted in a greater reduction in whole brain volume from baseline (SUNBEAM study: -0.41% vs -0.61%; RADIANCE study: -0.71% vs -0.94%).
Dr. Samit Hirawat, Chief Medical Officer of Bristol-Myers Squibb (BMS), stated, “Phase 3 clinical trials have demonstrated that Zeposia can significantly improve relapses and brain lesions associated with this devastating disease. The European Commission’s approval provides patients with active relapsing-remitting multiple sclerosis (RRMS) the opportunity to use Zeposia as a first-line treatment.”
Multiple Sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath covering nerves, causing destructive lesions that impede nerve cell signal transmission. This "signal disruption" can lead to associated symptoms and relapses. Relapsing-remitting multiple sclerosis (RRMS) is characterized by well-defined episodes of neurological deterioration. For patients with active RRMS, Zeposia is the only S1P receptor modulator approved for this indication.
Reference Source:
Bristol Myers Squibb Receives European Commission Approval for Zeposia (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease
(Original Title: BMS's New Multiple Sclerosis Drug Zeposia Approved by the EU)
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.