Novartis Afinitor Disperz receives FDA approval for partial seizures of TSC-related epilepsy
April 12, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On April 10, Novartis Pharmaceuticals said that the US FDA has approved its Afinitor DISPERZ® (everolimus oral suspension tablets) for children over 2 years of age and adult tuberous sclerosis (TSC)-related epileptic seizures Auxiliary treatment. Afinitor Disperz is the first drug therapy in the United States specifically designed to treat this disease.
TSC is a rare genetic disease affecting up to 1 million people worldwide. Approximately 85% of patients with TSC are affected by epilepsy, and uncontrolled seizures associated with TSC can debilitate patients. More than 60% of TSC patients experiencing seizures will stop responding to existing antiepileptic therapies. EXIST-3 is the first clinical phase 3 trial to demonstrate that Afinitor Disperz has a significant benefit in the adjuvant treatment of partial seizures associated with TSC. In addition, Afinitor is the only approved non-surgical treatment of TSC-associated non-cancerous brain tumors (subependymal giant cell astrocytoma, or SEGA) and TSC-associated renal tumors (renal angiomyolipoma). drug.
Ameet Mallik, executive vice president of Novartis Oncology USA, said: "Afinitor DISPERZ's FDA approval will have a significant impact on TSC patients with partial epileptic seizures."
The FDA approved Afinitor Disperz based on data from a key clinical phase 3 efficacy and safety trial EXIST-3 (EXamining everolimus In a Study of TSC). The study found that Afinitor Disperz significantly reduced the frequency of anti-therapeutic seizures associated with TSC in adjuvant therapy compared with placebo. Patients were randomized to a low dose of Afinitor Disperz (LE; 29.3%, 95% CI 18.8, 41.9; p=0.003) and high dose (He; 39.6%, compared with placebo (14.9%, 95% CI 0.1, 21.7). In patients with 95% CI 35.0, 48.7; p < 0.001, the median decline in seizure frequency was significantly greater than placebo. Compared with the placebo group (15.1%, 95% CI 9.2, 22.8), Afinitor LE (28.2%, 95% CI 20.3, 37.3) and HE (40.0%, 95% CI 31.5, 49.0; p < 0.001) epilepsy The response rate (≥50%) is also higher. Adverse events that reported more than 15% of the most common causes in the core phase included stomatitis, diarrhea, nasopharyngitis, upper respiratory tract infections, and fever.
Afinitor acts by inhibiting the mammalian target of rapamycin (mTOR), a protein that regulates a variety of cellular functions. In TSC, inactivating mutations in the TSC 1 or TSC 2 gene result in the formation of systemic hamartoma, as well as the formation of seizures and epilepsy. Overactivation of mTOR leads to neuronal dysplasia, axonal dysplasia and dendritic formation, increased excitatory synaptic currents, decreased myelination, and disruption of the cortical structure leading to neuronal development and dysfunction. The use of mTOR inhibitors in animal models of brain mTOR disorders prolongs survival, inhibits seizures, prevents new epileptic seizures, and prevents premature death. (Sina Pharmaceutical Compilation / David)
Reference source: Novartis drug Afinitor DISPERZ® receiving FDA approval to treat TSC-associated partial-onset seizures
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