Kygevvi (doxecitine;doxribtimine)
- Region
- 🇪🇺 EU
- Active substance
- doxecitine;doxribtimine
- Company
- UCB Pharma
- Status
- Authorised
- Therapeutic area
- Mitochondrial Diseases
- CHMP opinion
- Thu 29 Jan 2026
- EU approval
- Thu 26 Mar 2026
- Designations
- Orphan, PRIME, Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/005119
- ATC
- A16AX29
- Official record
- www.ema.europa.eu
Indication
Kygevvi is indicated for the treatment of paediatric and adult patients with genetically confirmed thymidine kinase 2 deficiency (TK2d) with an age of symptom onset on or before 12 years.
Regulatory milestones
Kygevvi (doxecitine;doxribtimine) approved in the EU
Marketing authorisation to UCB Pharma; Orphan, PRIME, Exceptional circumstances · source
Kygevvi (doxecitine;doxribtimine): CHMP positive opinion
UCB Pharma; Orphan, PRIME, Exceptional circumstances · source
FDA approves Kygevvi (doxecitine, doxribtimine), a new medicine
Ucb Inc; NDA219792; New molecular entity, Priority review; for solution · source
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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.