Novartis' Multiple Sclerosis Drug Data Shows Most Patients Remain With No Disability Progression For Up To Six Years
Novartis' Multiple Sclerosis Drug Data Shows Most Patients Remain With No Disability Progression For Up To Six Years
Novartis AG (NYSE:NVS) released new data Wednesday from the ALITHIOS open-label extension study.
諾華製藥（NYSE:NVS）週三發佈了來自ALITHIOS開放性延續研究的新數據。
Data show first-line Kesimpta (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from Sanofi SA's (NASDAQ:SNY) Aubagio (teriflunomide).
數據顯示，與那些從賽諾菲安萬特（NASDAQ:SNY）的Aubagio（特立氟胺）轉換而來的近期診斷（≤3年）和未經治療（RDTN）的複發性多發性硬化（RMS）患者相比，首線Kesimpta（ofatumumab）治療長達六年可降低殘疾和疾病進展。
These data will be presented at the European Committee for Treatment and Research in Multiple Sclerosis.
這些數據將在歐洲多發性硬化症治療和研究委員會上進行展示。
Also Read: Goldman Sachs Shifts Stance On Novartis, Cites Lack Of Near-Term Catalysts.
高盛發表報告稱，諾華製藥的近期影響因素不足。
Data from the overall ALITHIOS study population showed that continuous use of Kesimpta was associated with numerically fewer six-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) events up to six years compared to those who switched from teriflunomide.
來自ALITHIOS總體研究人群的數據顯示，與從特立氟胺轉換的患者相比，持續使用Kesimpta與6個月確認性殘疾惡化（6mCDW）和進展無關的復發活動（6mPIRA）事件在六年內出現較少。
RDTN patients receiving continuous Kesimpta were more likely to remain free from 6mCDW than those who switched to Kesimpta from teriflunomide (83.4% vs. 76.3%).
RDTN患者持續使用Kesimpta的6mCDW自由率高於那些從特立氟胺轉換到Kesimpta的患者（83.4% vs. 76.3%）。
RDTN patients receiving continuous Kesimpta were also more likely to be free of 6mPIRA vs. switching from teriflunomide (88.9% vs. 83.3%).
RDTN患者持續使用Kesimpta的6mPIRA自由率也高於從特立氟胺轉換的患者（88.9% vs. 83.3%）。
A separate U.S.-based single-arm OLIKOS Phase 3b study showed that at 12 months, all clinically stable RMS patients who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions, a commonly used marker of disease activity, compared to baseline.
一項獨立的美國單臂OLIKOS 30億期研究顯示，處於臨床穩定狀態的所有RMS患者從靜脈注射的抗CD20療法轉換到Kesimpta後，與基線相比未觀察到新的gadolinium增強（Gd +）T1病變，這是一種常用的疾病活動標記。
Tuesday, the FDA approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease.
美國食品藥物管理局批准了諾華製藥的Kisqali（利柔曲唑）與芳香化酶抑制劑聯合使用，用於輔助治療激素受體陽性/人表皮生長因子受體2陰性的Ⅱ期和Ⅲ期早期乳腺癌高復發風險患者，包括那些淋巴結陰性疾病患者。
The approval is based on results from the pivotal Phase 3 NATALEE trial, which showed a significant and clinically meaningful 25.1% reduction in risk of disease recurrence.
該批准基於關鍵三期NATALEE試驗的結果，顯示疾病復發風險顯著且臨床意義重大地降低了25.1%。
Price Action: Novartis stock is down 0.1% at $115.85 at last check Wednesday.
股價走勢：截至上週三最後一次檢查，諾華製藥股價下跌0.1%，至115.85美元。
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Image: Wikimedia Commons
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譯文內容由第三人軟體翻譯。