Biogen secures exceptional EU nod for ALS drug Qalsody
Biogen (Nasdaq: BIIB) has announced European approval for Qalsody (tofersen), for certain amyotrophic lateral sclerosis (ALS) patients, under exceptional circumstances.
This approach is recommended when the benefit/risk assessment of a treatment is determined to be positive but the rarity of the condition prevents comprehensive data from being gathered.
Qalsody, an antisense oligonucleotide (ASO), works by binding to SOD1 mRNA to reduce SOD1 protein production. It also has Accelerated Approval in the USA, and Biogen is working with regulatory authorities in other regions to expand access.
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