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(RTTNews) - Biogen Inc. (BIIB) said that the European Commission has granted marketing authorization under exceptional circumstances and maintained orphan designation for Qalsody (tofersen) for the treatment of adults with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 gene (SOD1-ALS).

Qalsody is the first treatment approved in the European Union to target a genetic cause of ALS, also known as motor neuron disease.

Qalsody is Biogen's third rare disease therapy to be approved in the European Union.

Through the Biogen early access program, about 330 people with SOD1-ALS have received Qalsody across 18 EU countries. Qalsody is also approved for use in the United States and Biogen is engaging with regulatory authorities in other regions, the company said.

Biogen licensed Qalsody from Ionis Pharmaceuticals Inc. under a collaborative development and license agreement. QALSODY was discovered by Ionis.

Amyotrophic lateral sclerosis (ALS) is a rare, progressive and fatal neurodegenerative disease that results in the loss of motor neurons in the brain and the spinal cord that are responsible for controlling voluntary muscle movement. People with ALS experience muscle weakness and atrophy, causing them to lose independence as they steadily lose the ability to move, speak, eat, and eventually breathe. Average life expectancy for people with ALS is three to five years from time of symptom onset.

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