Shots:
- The opinion was based on the results from the P-III (VALOR) trial evaluating the safety & efficacy of Qalsody (100mg) vs PBO in ALS patients (n=108) associated with SOD1 mutations. The 1EPs of the study include changes in ALSFRS-R total score from baseline to wk.28 & 2EPs includes change in total cerebrospinal fluid SOD1 protein concentration, plasma NfL, slow vital capacity & handheld dynamometry in 16 muscles
- The results depicted a 60% reduction in plasma NfL & an improvement in physical abilities measured by ALSFRS-R total score with Qalsody vs PBO
- Qalsody, an antisense oligonucleotide (ASO), binds to SOD1 mRNA to reduce SOD1 protein production. Additionally, Qalsody received the US FDA’s accelerated approval for ALS
Ref: Biogen | Image: Biogen | Press Release
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