lundbeck has received orphan drug status from both the US FDA and the European EMA for Lu AG13909, a monoclonal antibody for the treatment of congenital adrenal hyperplasia (CAH). The company is now expanding an ongoing Phase I/II study to include patients in North America and seven European countries, with first enrollment in late June 2025.
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Published June 24, 2025
Lundbeck receives orphan drug designation for Lu AG13909
Notes
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