Eladocagene Exuparvovec: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Eladocagene Exuparvovec. Educational only — not medical advice.

Labeled uses

KEBILIDI (eladocagene exuparvovec-tneq) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. This indication is approved under accelerated approval based on the change from baseline in gross motor milestone achievement at 48 weeks post treatment [see Clinical Studies (14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Source: FDA labeling via NIH DailyMed (set 9d6a6401…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.