- Biogen Inc BIIB This was announced by the New England Journal of Medicine (NEJM). published detailed results from the Phase 3 VALOR study of Tofersen in superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
- The journal also published the combined analysis of VALOR and its open-label extension study (OLE).
- Data from the combined analysis was included in Biogen’s submission for Tofersen, which was recently accepted by the FDA for priority review, with an action date under the Prescription Drug User Fee Act of January 25, 2023.
- As reported in October 2021, VALOR not hit the primary endpoint. However, trends of reduced disease progression were observed across multiple secondary and exploratory endpoints.
- The combined 12-month data from VALOR and OLE showed sustained reductions in SOD1 protein (a marker of target binding) and neurofilament (marker of neurodegeneration). It also slowed the decline in clinical function, respiratory function, strength and quality of life with earlier initiation of Tofersen.
- The most common adverse events (AEs) were procedural pain, headache, pain in arms or legs, falls, and back pain. Most AEs in both VALOR and OLE were mild to moderate. Serious neurological events were reported in 6.7% of participants receiving Tofersen in VALOR and his OLE.
- Price promotion: BIIB shares traded 2.44% higher at $204.20 premarket on the latest check Thursday.
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