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  • 'Altuviiio' for hemophilia A expected to be marketed in KOR
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Nov 25, 2024 05:53am
A new HSF therapy
Sanofi applies for the Ministry of Food and Drug Safety (MFDS) approval
Demonstrated the efficacy through the Phase 3 trial¡¦reduces ABR
'Altuviiio,' a new once-weekly administered hemophilia A drug, is expected to be marketed in South Korea.

According to industry sources, Sanofi-Aventis has recently submitted an application for approval of Altuviiio (efanesoctocog alfa).

The Ministry of Food and Drug Safety (MFDS) granted this drug an Orphan Drug Designation (ODD) in May. Altuviiio recently received the 'Global Innovative products on Fast Track (GIFT)' designation.

Altuviiio is the first hemophilia therapy to receive an orphan drug designation from the MFDS in South Korea other than a non-factor agent, which received the designation three years ago.

Altuviiio is a first-in-class high sustained factor (HSF) therapy for hemophilia A. With o
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