Europe Approves Biogen's Tofersen For Adult Patients With Rare Type Of Neurodegenerative Disorder
Portfolio Pulse from Vandana Singh
The European Commission has granted marketing authorization for Biogen's Qalsody (tofersen) for treating amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene. This is the first treatment in the EU targeting a genetic cause of ALS. Despite the Phase 3 VALOR study showing numerical but not statistically significant efficacy, Qalsody has shown a significant reduction in neurofilament light chain levels. Biogen licensed Qalsody from Ionis Pharmaceuticals.
May 31, 2024 | 2:25 pm
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POSITIVE IMPACT
Biogen's Qalsody (tofersen) has received marketing authorization in the EU for treating SOD1-ALS, marking a significant milestone as the first genetic-targeted ALS treatment in the region. This approval could boost Biogen's revenue and market position in the rare disease segment.
The approval of Qalsody in the EU is a significant milestone for Biogen, as it is the first treatment targeting a genetic cause of ALS. This could lead to increased revenue and strengthen Biogen's market position in the rare disease segment.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100
POSITIVE IMPACT
Ionis Pharmaceuticals, which licensed Qalsody to Biogen, stands to benefit from the EU approval of the drug. This could enhance Ionis's reputation and potentially lead to future collaborations and licensing deals.
Ionis Pharmaceuticals, as the licensor of Qalsody, will likely see positive impacts from the EU approval. This could enhance its reputation and open doors for future collaborations and licensing opportunities.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 70