Shots:

• The US FDA approval was based on RWE from the (EPIK-P1) study evaluating Vijoice in adult & pediatric patients aged ≥2yrs. with PIK3CA-related overgrowth spectrum
• The results showed a 74% reduction in target lesion volume with a mean reduction of 13.7%, 27% with a confirmed response with ≥20% reduction in PROS target lesion volume @24wk., no patients experienced disease progression at the time of primary analysis
• Additionally, improvements in pain (90%), fatigue (76%), vascular malformation (79%), limb asymmetry (69%) & disseminated intravascular coagulation (55%). The company provides a patient support program including assistance to access medication, financial resources & continued education

Ref: Novartis | Image: Novartis