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  • Pre-approval of benefits for Spinraza were approved
  • by Lee, Hye-Kyung | translator Choi HeeYoung | Aug 10, 2020 06:00am

5 out of 6 cases for pre-approval of benefits for Spinal Muscular Atrophy (SMA) treatment 'Spinraza (Nusinersen)' last month were approved.

After approval of Spinraza benefits, a monitoring report must be submitted every four months before administration of maintenance doses, and all 24 cases of administration monitoring have been approved.

In the case of Soliris (Eculizumab), which was the subject of pre-approval prior to Spinraza, 3 new applications for pre-approval for paroxysmal nocturnal hemoglobinuria (PNH) and 40 monitoring were all approved. However, only one out of two applications for reconsideration was approved.

Kim Sun-min, President of the HIRA released the results of the 5 items deliberated b
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