WESTON (dpa-AFX) - 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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