Shots:
- FDA has approved Kygevvi (2g/2g; PO) for adults & pediatric pts with TK2d whose symptom onset occurred ≤12yrs. of age. Kygevvi is expected to launch in the US by Q1’26, & is under EMA’s review, with additional regulatory filings planned
- Approval was backed by a P-II trial, 2 retrospective chart review studies, & an expanded access use program comparing Kygevvi vs pyrimidine nucleosides in 82 pts, with OS assessed against untreated controls who were matched to treated pts using age of TK2d symptom onset
- Among 78 matched pairs, Kygevvi reduced the risk of death by ~86%, with a median TK2d onset at 1.5yrs., a median treatment duration of 4yrs., & a median dose of 762 mg/kg/day
Ref: UCB | Image: UCB | Press Release
Related News:- UCB Reports Results from BE HEARD Trials on Bimzelx (Bimekizumab-bkzx) to Treat Hidradenitis Suppurativa
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