NOVARTIS EUROPHARM LIMITED

EMA Grants Conditional Approval for Vijoice, First Treatment for Rare PIK3CA-Related Overgrowth Disorders

- The European Medicines Agency has recommended conditional marketing authorization for Vijoice (alpelisib) to treat severe PIK3CA-related overgrowth spectrum disorders in adults and children aged 2 years and older. - The PI3 kinase inhibitor demonstrated a 37.5% response rate in a compassionate use study, with 12 of 32 patients showing at least 20% reduction in lesion size after 24 weeks. - This represents the first authorized medicine for PROS disorders, which currently have no approved treatments and rely solely on supportive care including surgery. - The conditional approval allows early patient access while Novartis conducts additional studies to further confirm the drug's efficacy and safety profile.