"Expanded Treatment Opportunities for Fabry Disease Patients"... Approval Granted for Import of 'Elfabrio Injection'
Ministry of Food and Drug Safety Approves Import of Orphan Drug
The Ministry of Food and Drug Safety announced on the 21st that it has approved the imported orphan drug "Elfabrio Injection (Pegunigalsidase Alfa)" for the treatment of Fabry disease, a rare disorder.
Fabry disease is one of the lysosomal storage disorders caused by a deficiency of the enzyme alpha-galactosidase A. Symptoms include angiokeratoma (wart-like skin lesions), abdominal pain, proteinuria, pain in the fingers and toes, anhidrosis, hypohidrosis, and hearing and vision impairments.
Elfabrio Injection is a genetically engineered alpha-galactosidase produced in plant cell lines that supplements the deficient enzyme in Fabry disease patients, thereby reducing the accumulation of glycolipids and alleviating disease progression. It is used as a long-term enzyme replacement therapy for patients diagnosed with Fabry disease.
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The Ministry stated, "This approval is expected to provide new treatment opportunities for patients with Fabry disease."
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