FDA Grants Orphan Drug Status to Lundbeck's Cushing's Antibody Asedebart
Valby, Denmark – – September 16, 2026 -- The U.S. Food and Drug Administration has granted Orphan Drug Designation to asedebart (Lu AG13909), Lundbeck's investigational anti-ACTH monoclonal antibody, for the treatment of endogenous Cushing's syndrome.
FDA designation adds U.S. market exclusivity potential for Lundbeck's rare disease pipeline
The designation covers drugs and biologics intended for rare diseases and can provide tax credits for qualified clinical testing, exemption from certain FDA application fees, and up to seven years of market exclusivity if the drug is approved for the designated indication.