Antibody drug 'Fasenra' lands in KOR with EGPA indication
By Eo, Yun-Ho | translator Hong, Ji Yeon
24.12.02 05:39:00
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In the process of expanding approval criteria of the MFDS
Demonstrated non-equivalence to 'Nucala' based on the Phase 3 trial
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Astra Zeneca's Fasenra, an antibody drug for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA), is expected to be introduced in South Korea.According to industry sources on November 29, Astra Zeneca Korea has recently submitted an application to the Ministry of Food and Drug Safety (MFDS) for an expanded indication of Fasenra (benralizumab). The indication is for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) with polyangiitis.
Fasenra received the Orphan Drug Designation (ODD) for the EGPA indication in March. It received orphan drug designation from the U.S. Food and Drug Administration (FDA) in 2018.
AstraZeneca recently sho
Eo, Yun-Ho(unkindfish@dailypharm.com)
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