Novartis drug Afinitor significantly reduces seizures in TSC patients

pharmafile | April 21, 2016 | News story | Research and Development Afinitor, Novartis, Tuberous Sclerosis Complex, drug, seizure, seizures, tsc 

Novartis (SIX: NOVN) has announced the results from a Phase III clinical trial which shows that Afinitor (everolimus) significantly reduced treatment-resistant seizures associated with tuberous sclerosis complex (TSC), when used as an adjunctive therapy.

TSC is a rare genetic disorder affecting up to one million people worldwide, and Afinitor is the only approved non-surgical option indicated for treating non-cancerous brain and kidney tumours in certain patients with TSC.  

In the EXIST-3 study, 366 patients with TSC and treatment-resistant seizures were randomised to receive targeted concentrations of Afinitor titrated to low exposure, high exposure, or placebo. Between 30% and 40% of patients reported a significant reduction in frequency of seizures compared to only 15% with placebo.

The EXIST-3 study results show that Afinitor is the first adjunctive therapy to achieve clinically significant seizure control in TSC patients and will be the basis for the pursuit of regulatory approval for this new indication of the drug.

Alessandro Riva, global head of oncology and medical affairs at Novartis, says: “There has been a long-standing need to find a treatment option for TSC patients that provides control of treatment-resistant seizures and we are encouraged that data from the EXIST-3 study show everolimus may have this potential.”

Sean Murray

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