Shots:
- The CHMP has recommended Kygevvi (PO) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age, supported through EMA’s PRIME scheme. EC decision is expected by Q2’26
- Supportive evidence came from pooled data from 2 studies of Kygevvi in 39 pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.)
- Doxecitine & doxribtimine integrate into skeletal muscle mitochondrial DNA, restoring mtDNA copy number & improving muscle function in pts with TK2d
Ref: UCB | Image: UCB | Press Release
Related News: UCB Reports the US FDA’s Approval of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)
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