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US boost for Lundbeck’s Cushing’s drug candidate

Lundbeck has received orphan drug designation from the US FDA for asedebart, Lu AG13909, for the treatment of endogenous Cushing’s syndrome.
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Asedebart is an experimental monoclonal antibody targeting ACTH and is being developed for ACTH-dependent Cushing’s syndrome. A proof-of-concept study is underway to evaluate efficacy and safety in Cushing’s disease. Studies are also underway in classic congenital adrenal hyperplasia.

The drug previously received orphan drug designation in the EU for endogenous Cushing’s syndrome, as well as several corresponding designations for other ACTH-driven diseases in the EU, US and Japan.

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