Rare Drug for Treating Alpha-mannosidosis Approved for the First Time in Korea

Ministry of Food and Drug Safety Approves Import of Lamzedeju 10mg

The Ministry of Food and Drug Safety announced on January 12 that it has approved the import of the rare drug "Lamzedeju 10mg" (ingredient name: velmanase alfa), which is used to treat non-central nervous system symptoms in patients with alpha-mannosidosis.

Alpha-mannosidosis is a disorder caused by a deficiency of the lysosomal alpha-mannosidase enzyme, resulting in the accumulation of mannose-containing oligosaccharides that cannot be broken down. This leads to symptoms such as facial and skeletal abnormalities and immunodeficiency.

Lamzedeju is a recombinant human alpha-mannosidase enzyme. It supplements the deficient enzyme in patients with alpha-mannosidosis, thereby reducing the accumulation of mannose-containing oligosaccharides in organs and alleviating non-central nervous system symptoms.

Until now, there has been no approved treatment for patients with alpha-mannosidosis in Korea. However, with this approval, patients are expected to have new treatment opportunities.

The Ministry of Food and Drug Safety stated, "We will continue to do our utmost to ensure that new treatments are supplied quickly to patients with rare diseases, expanding their treatment opportunities based on our expertise in regulatory science."