Mitsubishi Tanabe Pharma America Presents Final Results from the Global, Phase 3b MT-1186-A02 Post-marketing Study of RADICAVA® (edaravone) in ALS [Yahoo! Finance]
MITSUBISHI CH GRP U/ADR (MTLHY)
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mitsubishichem-hd.co.jp/english/ir
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Source: Yahoo! Finance
the global, multi-center, double-blind, Phase 3b MT-1186-A02 study of oral edaravone in amyotrophic lateral sclerosis (ALS). Final results showed the daily dosing regimen of RADICAVA ORS ® (edaravone) did not show superiority to the U.S. Food and Drug Administration (FDA) approved on/off dosing regimen based on the primary endpoint of Combined Assessment of Function and Survival (CAFS) at 48 weeks. Both dosing regimens provided comparable change in ALSFRS-R from baseline to week 48. These findings suggest that the current on/off regimen of RADICAVA ORS is the most appropriate regimen for people living with ALS based on efficacy and safety findings from studies MT-1186-A02 and MCI186-19. ALSFRS-R changes observed at week 48 in Study MT-1186-A02 of RADICAVA ORS were similar to the post hoc assessment of the previous Japanese, Phase 3 Study MCI186-19 of intravenous (IV) RADICAVA ® (edaravone). The MT-1186-A02 study found no new safety concerns and reinforces edaravone as a safe product.
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