Novartis announced that the USFDA has approved Afinitor Disperz (everolimus tablets for oral suspension), 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 US specifically indicated for the treatment of this condition.

TSC is a rare genetic disorder affecting up to one million people worldwide. EXIST-3 (EXamining everolimus In a Study of TSC)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. Furthermore, Afinitor is the only approved non-surgical option indicated for treating TSC-associated non-cancerous brain tumors (subependymal giant cell astrocytoma, or SEGA) and TSC-associated kidney tumors (renal angiomyolipoma). 

We are pleased that this latest approval for Afinitor Disperz in the US will make an important difference to patients with tuberous sclerosis complex who experience partial-onset seizures, one of the most debilitating manifestations of TSC. This is a welcome advance that reinforces the commitment of Novartis to patients with rare diseases, said Ameet Mallik, executive vice president, Novartis Oncology US.

Afinitor Disperz is the first adjunctive treatment approved in the US specifically for adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. The product is also approved in more than 30 countries, including EU member states, for the treatment of patients with TSC-associated seizures. Afinitor/Votubia is also approved in more than 95 countries, including the US, EU member states and Japan, for treatment of certain patients with TSC-associated subependymal giant cell astrocytoma (SEGA) and TSC-associated renal angiomyolipoma. – Medical Buyer Bureau


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