The Ministry of Food and Drug Safety announced on December 23 that it has approved the import of the rare drug "Altuvio Injection" (active ingredient: efanesoctocog alfa).
This medication is a recombinant coagulation factor VIII agent for the prevention and management of bleeding in adults and children with hemophilia A. Compared to previously approved drugs, it has an extended half-life, allowing for once-weekly dosing as a long-acting therapy.
Congenital hemophilia A is a rare blood disorder characterized by a deficiency of coagulation factor VIII, which can cause life-threatening bleeding in response to trauma, as well as recurrent bleeding into soft tissues and joints.
The Ministry designated this drug as a target for the Global Innovative Product Fast-Track (GIFT) review system and expedited its review and approval.
A Ministry official stated, "We expect that treatment accessibility for adult and pediatric patients with congenital hemophilia A will be improved," adding, "We will continue to do our best to ensure that safe and effective therapies for life-threatening, rare, or serious diseases can be supplied quickly."
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