Kygevvi (doxecitine, doxribtimine)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- doxecitine, doxribtimine
- Company
- Ucb Inc
- Status
- Approved
- FDA approval
- Mon 03 Nov 2025
- Designations
- New molecular entity, Priority review
- Application
- NDA219792
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 26 Mar 2026🇪🇺 EU approval (EC decision)
Kygevvi (doxecitine;doxribtimine) approved in the EU
Marketing authorisation to UCB Pharma; Orphan, PRIME, Exceptional circumstances · source
Thu 29 Jan 2026🇪🇺 CHMP positive opinion
Kygevvi (doxecitine;doxribtimine): CHMP positive opinion
UCB Pharma; Orphan, PRIME, Exceptional circumstances · source
Mon 03 Nov 2025🇺🇸 FDA approval
FDA approves Kygevvi (doxecitine, doxribtimine), a new medicine
Ucb Inc; NDA219792; New molecular entity, Priority review; for solution · source
Same substance in other markets
- 🇪🇺 Kygevvi Authorised · UCB Pharma
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.