Lundbeck's Lu AG13909 Secures Orphan Drug Status In US And EU For Rare Adrenal Disorder

(RTTNews) - Lundbeck announced that its investigational drug Lu AG13909 received orphan drug designation from the US Food and Drug Administration on 12 May 2025 and from the European Medicines Agency (EMA) on 20 June 2025.

Lu AG13909 is a novel, humanised monoclonal antibody, under investigation for the treatment of patients with Congenital adrenal hyperplasia (CAH), a rare genetic disease.

CAH is characterised by impaired cortisol production and elevated levels of adrenocorticotropic hormone (ACTH), a hormone produced in the brain and involved in the regulation of multiple functions in the body. Elevated levels of ACTH lead to additional adrenal hormone imbalance, ultimately resulting in multiple developmental disturbances including symptoms related to the central nervous system, and long-term health concerns.

Lundbeck noted that it is currently expanding an ongoing Phase I/II clinical open-label trial, evaluating the efficacy and safety of anti-ACTH antibody Lu AG13909 in adults with classic CAH. The trial will open for enrolment in North America and seven countries across Europe, with the first sites opening in late June 2025.

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