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  • ALS drug Qalsody is approved in Korea with a condition
  • by Lee, Hye-Kyung | translator Alice Kang | Aug 22, 2025 06:07am
Required to submit clinical trial results after approval
MFDS, CPAC decides to grant conditional approval for the drug
The ALS treatment ¡®Qalsody (tofersen)¡¯ has been approved under the condition that the results of its therapeutic confirmatory clinical trial be submitted later.

According to the advisory council¡¯s review results regarding the safety and efficacy of Qalsody, which was released by the Ministry of Food and Drug Safety on the 20th, the council saw consensus on the need to grant conditional approval for Qalsody, given how ALS worsens over time and treatment options are limited.

Biogen's Qalsody is a nucleic acid therapy that binds to SOD1 mRNA in patients with ALS caused by mutations in the superoxide dismutase 1 (SOD1) gene, reducing the synthesis of mutated proteins (SOD1). It received domestic approval from th
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