USFDAJul 22, 2026, 08:02 AM
Monopar Begins Rolling NDA Submission for ALXN1840 in Wilson Disease
AI Summary
Monopar Therapeutics announced the initiation of a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for ALXN1840 (tiomolibdate choline) for the treatment of Wilson disease. The FDA has authorized this rolling submission, allowing the company to submit and have sections reviewed as they are completed. ALXN1840, a first-in-class albumin tripartite complex activator, has previously received Fast Track, Orphan Drug, and Rare Pediatric Disease designations, with the latter offering potential for a Priority Review Voucher upon approval.
Key Highlights
- Monopar initiated rolling NDA submission for ALXN1840 to the U.S. Food and Drug Administration (FDA).
- ALXN1840 is a first-in-class albumin tripartite complex (ATC) activator for Wilson disease.
- FDA authorized the rolling submission, allowing completed sections to be reviewed as submitted.
- If approved, ALXN1840 would be the first novel mechanism of action for Wilson disease in decades.
- ALXN1840 received Fast Track, Orphan Drug, and Rare Pediatric Disease (RPD) designations.
- RPD designation provides potential for a pediatric Priority Review Voucher (PRV) upon NDA approval.
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