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  • ALS drug Qalsody to be commercialized in Korea
  • by Eo, Yun-Ho | translator Alice Kang | Jan 31, 2025 05:56am
MFDS¡¯s marketing authorization review under progress
Approved in the US and other countries based on biomarker validations
Commercialization of the new drug ¡®Qalsody¡¯ for amyotrophic lateral sclerosis is expected in Korea.

According to industry sources, Qalsody (tofersen), Biogen¡¯s drug indicated for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the Superoxide Dismutase 1 (OD1) gene mutation, is undergoing a review for marketing authorization by the Ministry of Food and Drug Safety.

The drug had been designated an orphan drug in August last year.

Qalsody, which was developed by Biogen, is an ASO (antisense oligonucleotide) drug that blocks the messenger ribonucleic acid (mRNA) associated with the SOD1 gene mutation to prevent its expression.

The drug was approved by the US FDA in June o
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