Shots:
- 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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