BIO PRODUCTS LABORATORY LIMITED

FDA Grants Orphan Drug Designation to COAGADEX for Rare Bleeding Disorder Associated with AL Amyloidosis

- The FDA has granted Orphan Drug Designation to Kedrion Biopharma's COAGADEX for treating acquired Factor X deficiency, a rare blood disorder affecting fewer than one in one million people globally. - COAGADEX, already approved in 38 countries for hereditary Factor X deficiency, will be evaluated in a new clinical trial for patients with acquired deficiency caused by AL amyloidosis. - The condition occurs when amyloid fibrils bind to and reduce circulating Factor X levels, significantly increasing bleeding risk in affected patients. - Patient recruitment is underway for the trial, which will focus on moderate and severe forms of acquired Factor X deficiency with coagulant activity levels below 50% of normal.