Shots:
- UCB reported the P-III study (n=87; ages 1-35yrs.) of adjunctive fenfluramine vs. PBO in CDKL5 Deficiency Disorder (CDD) diagnosis and uncontrolled seizure pts.
- The P-III study met its 1EP (median % reduction in countable motor seizure frequency) and most key 2EPs. Fenfluramine was well tolerated with a consistent safety profile in prior DS/LGS studies
- UCB is conducting a 54wks. extension study to assess the long-term safety and tolerability of fenfluramine in pediatric and adult pts. with CDD and planning to submit for regulatory approval soon
Ref: PRnewswire | Image: UCB | Press Release
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