The Ministry of Food and Drug Safety (MFDS) announced on the 13th that it has approved the orphan drug ‘Hemgenix Inj (etranacogene dezaparvovec)’ imported by CSL Behring Korea.

Hemgenix is used to treat moderate-to-severe hemophilia B (congenital blood clotting factor IX deficiency) in adults without a history of Factor IX inhibitors. The drug is expected to provide new treatment opportunities for hemophilia B patients by offering a long-term, single-shot treatment option, unlike existing treatments.

The MFDS explained that the quality, safety and effectiveness, manufacturing and quality control standards of Hemgenixwere thoroughly reviewed and evaluated scientifically in accordance wi