Novartis announced that the Food and Drug Administration (FDA) has approved Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of patients aged ≥2 years with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
This approval marks Afinitor Disperz as the first approved treatment for this condition. Afinitor Disperz is already approved to treat TSC-associated subependymal giant cell astrocytoma (SEGA) in patients aged ≥1 year that require therapeutic intervention but cannot be curatively resected.
The approval was based on the Phase 3, randomized, double-blind, placebo-controlled EXIST-3 (EXamining everolimus In a Study of TSC) study which evaluated adjunctive Afinitor Disperz (low exposure: 3–7ng/mL; high exposure: 9–15ng/mL) in patients with treatment-resistant TSC-associated partial-onset seizures, defined as inadequate control of partial-onset seizures despite use of ≥2 sequential regimens of single or combined anti-epileptic drugs.
In the study, adjunctive treatment with Afinitor Disperz demonstrated a significant benefit by reducing the frequency of treatment-resistant seizures associated with TSC vs placebo. There was a greater median percentage reduction from baseline in seizure frequency among patients randomized to Afinitor Disperz low exposure (29.3%, 95% CI: 18.8, 41.9; P=0.003) as well as high exposure (39.6%, 95% CI: 35.0, 48.7; P<0.001) vs placebo (14.9%, 95% CI: 0.1, 21.7).
In addition, seizure response rate (≥50% reduction) was also greater with Afinitor Disperz low exposure (28.2%, 95% CI: 20.3, 37.3) and high exposure (40.0%, 95% CI: 31.5, 49.0; P<0.001) vs placebo (15.1%, 95% CI: 9.2, 22.8).
Stomatitis, diarrhea, nasopharyngitis, upper respiratory tract infection, and pyrexia were the most common adverse events observed in the Afinitor Disperz arms.
Afinitor Disperz, a mammalian target of rapamycin (mTOR) inhibitor, is available as 2mg, 3mg, and 5mg strength tablets for oral suspension in 28-count blisters.
For more information call (888) 669-6682 or visit Novartis.com.