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'Altuviiio' for hemophilia A expected to be marketed in KOR

By Eo, Yun-Ho | translator Hong, Ji Yeon

24.11.25 05:39:30

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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 sustain

Eo, Yun-Ho(unkindfish@dailypharm.com)
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