References in periodicals archive ?
Novartis' Afinitor DISPERZ (everolimus tablets for oral suspension), has been approved by the FDA for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
Afinitor DISPERZ is now the first approved pharmacologic therapy in the U.S.
EXIST-3 is the first Phase III study to demonstrate the significant benefit of adjunctive Afinitor DISPERZ in the treatment of patients with TSC-associated partial-onset seizures.
The approval was based on efficacy and safety data from a pivotal Phase III study, EXIST-3 (Examining everolimus In a Study of TSC), which found that when used as an adjunctive therapy, Afinitor DISPERZ significantly reduced the frequency of treatment-resistant seizures associated with TSC compared to placebo.