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  • PO SMA tx Indication of Evrysdi expands
  • by Eo, Yun-Ho | translator Choi HeeYoung | Dec 21, 2022 06:05am
Obtain additional approval from the MFDS
Verification of validity through RAINBOWFISH phase 2
Evrysdi, a PO SMA treatment, can be used for infants under 2 months in Korea. According to related industries, Evrysdi recently obtained approval from the Ministry of Food and Drug Safety to expand the indication. Accordingly, Evrysdi can be administered to newborns before symptoms appear in Korea. The expansion of neonatal indications was based on the results of phase 2 clinical RAINBOWFISH. In the study, the efficacy, safety, pharmacokinetics, and pharmacokinetics of Evrysdi were evaluated for asymptomatic SMA patients who were genetically diagnosed up to 6 weeks of age regardless of the number of SMN2 genes. The primary target point was set as the proportion of patients who could sit without assistance or support f
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