Shots:
- The EC has approved kygevvi (doxecitine and doxribtimine) under exceptional circumstances for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age
- Supportive evidence for approval came from pooled data from 2 studies of Kygevvi in pts with genetically confirmed TK2d & symptom onset ≤12yrs. The studies showed improved functional outcomes & survival vs matched external controls after long-term treatment (>5yrs.)
- Post-treatment, 84% (26/31) of patients regained ≥1 motor milestone. Ventilatory support initiation decreased (24% post vs 46% pre), with 22% discontinuing support. Feeding support also improved, with only 14% initiating post-treatment and some later discontinuing
Ref: UCB | Image: UCB | Press Release
Related News: UCB Reports the CHMP Positive Opinion of Kygevvi (Doxecitine + Doxribtimine) for Thymidine Kinase 2 Deficiency (TK2d)
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