Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease
Monopar Therapeutics has initiated a rolling submission of a New Drug Application to the FDA for ALXN1840, a first-in-class treatment for Wilson disease. The FDA authorized the rolling review process, allowing the company to submit completed sections for review while finalizing the remainder of the application.
Key figures
- Drug Name
- ALXN1840 (tiomolibdate choline, TMC)
- Phase Of Trial
- Phase 3
- Patient count
- 266
- Patient years
- 645
- Trial duration weeks
- 48
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