EMA — authorised 26 March 2026
- Application: EMEA/H/C/005119
- Marketing authorisation holder: UCB Pharma
- Local brand name: Kygevvi
- 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.
- Pathway: exceptional circumstances, orphan, PRIME
- Status: approved
On 26 March 2026, the European Medicines Agency (EMA) granted marketing authorisation for Kygevvi, a treatment for thymidine kinase 2 deficiency (TK2d). This rare genetic disorder affects the body's ability to produce energy. Kygevvi is indicated for patients with genetically confirmed TK2d who experienced symptom onset at or before 12 years of age. The marketing authorisation was granted under exceptional circumstances, as an orphan medicine, and through the PRIME scheme.