Published on 31 May 2024 on Zacks via Yahoo Finance
Biogen (BIIB) Gets EU Approval for Rare Disease Drug Qalsody
Biogen BIIB announced that the European Commission (EC) has granted marketing approval to Qalsody for treating patients with amyotrophic lateral sclerosis (“ALS”) with superoxide dismutase 1 (“SOD1”) mutation.
The EC has granted marketing authorization to Qalsody under exceptional circumstances. When a treatment is deemed to have a positive benefit/risk assessment but gathering comprehensive data is difficult due to the rarity of the condition, regulatory agencies like the European Medicines Agency (EMA) may recommend granting marketing authorization under such circumstances. The EC has also maintained an orphan designation for Qalsody.