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The P-III (FUSION) trial met its 1EP with ulefnersen, showing improvements in functional impairment & survival in a joint rank analysis of time to death or permanent ventilation, time to rescue, & change in ALSFRS-R from baseline to Day 505 vs PBO in pts with ALS caused by mutations in the fused in sarcoma (FUS) gene
Trial also showed improvements in 2EPs, incl. reductions in serum neurofilament light chain (NfL) from baseline & longer time to the earliest of death, permanent ventilation, rescue, or withdrawal due to disease progression
Otsuka & Ionis plan further analyses of FUSION & the ongoing OLE, discussions with the FDA & global health authorities on potential expedited regulatory pathways, with detailed results expected at a future congress & in a publication
Ref: Businesswire | Image: Ionis & Otsuka | Press Release
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The post Otsuka and Ionis Report P-III (FUSION) Trial Results for Ulefnersen in FUS-ALS appeared first on PharmaShots.
Otsuka and Ionis Report P-III (FUSION) Trial Results for Ulefnersen in FUS-ALS | PharmaVoice