An Indian pharmaceutical company has received US FDA approval for its generic version of everolimus tablets, intended to treat adult and pediatric patients aged one year and older with tuberous sclerosis complex (TSC) and subependymal giant cell astrocytoma (SEGA) that require therapeutic intervention but cannot be surgically resected. Clinical evidence The safety and efficacy of everolimus were originally evaluated in two clinical trials involving adult and pediatric patients with TSC and SEGA. In study 1 (n = 117), everolimus achieved a significantly higher SEGA response rate (≥50% reduction in SEGA tumor volume) in patients compared to a placebo (35% vs. 0%).
It also demonstrated a median response duration of 5.3 months with no need for surgical intervention. After 8.4 months, SEGA progression occurred in 15.4% of patients in the placebo group but in none of the everolimus group. In…
