The U.S. FDA grants orphan drug designation for Lundbeck's investigational anti-ACTH monoclonal antibody asedebart for treatment of endogenous Cushing's syndrome

The FDA granted Orphan Drug Designation to Lundbeck's investigational anti-ACTH monoclonal antibody, asedebart (Lu AG13909), for endogenous Cushing's syndrome. The designation supports development of the treatment for a rare endocrine disorder and may provide incentives including market exclusivity if ultimately approved, though the drug remains investigational.