Biogen’s Qalsody (tofersen) Receives CHMP’s Positive Opinion for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
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- 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
Related News:- Biogen and Ionis Receive the US FDA’s Approval of Qalsody (tofersen) for the Treatment of Amyotrophic Lateral Sclerosis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
