Eli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main Goal
Eli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main Goal
禮來公司在住院新冠肺炎患者中的巴利替尼研究未能達到主要目標
- Eli Lilly And Co (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) have reported results from the COV-BARRIER Phase 3 study evaluating baricitinib plus standard of care (SoC) versus placebo plus SoC in hospitalized COVID-19 patients.
- The trial did not meet statistical significance on the primary endpoint of the proportion of participants progressing to non-invasive ventilation or death by Day 28.
- Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death.
- Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction in death from any cause by 38%.
- A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients. It was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC.
- The frequency of adverse events was generally similar in the baricitinib and placebo groups.
- Severe infections and venous thromboembolism occurred in 8.5% and 2.7% of patients treated with baricitinib, respectively, versus 9.8 % and 2.5% on placebo.
- Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months.
- The company will share the data from the study with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib in hospitalized COVID-19 patients.
- Yesterday, the FDA extended the review period for baricitinib in atopic dermatitis by three months.
- Price Action: LLY shares are up 0.3% at $182.8 in premarket trading on the last check Thursday, while INCY shares closed 2.2% lower at $81.38 on Wednesday.
- Eli Lilly And Co (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) have reported results from the COV-BARRIER Phase 3 study evaluating baricitinib plus standard of care (SoC) versus placebo plus SoC in hospitalized COVID-19 patients.
- The trial did not meet statistical significance on the primary endpoint of the proportion of participants progressing to non-invasive ventilation or death by Day 28.
- Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death.
- Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction in death from any cause by 38%.
- A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients. It was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC.
- The frequency of adverse events was generally similar in the baricitinib and placebo groups.
- Severe infections and venous thromboembolism occurred in 8.5% and 2.7% of patients treated with baricitinib, respectively, versus 9.8 % and 2.5% on placebo.
- Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months.
- The company will share the data from the study with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib in hospitalized COVID-19 patients.
- Yesterday, the FDA extended the review period for baricitinib in atopic dermatitis by three months.
- Price Action: LLY shares are up 0.3% at $182.8 in premarket trading on the last check Thursday, while INCY shares closed 2.2% lower at $81.38 on Wednesday.
- 禮來公司(紐約證券交易所股票代碼：LLY)和Incell公司美國疾病控制與預防中心(納斯達克股票代碼：INCY)已經報告了COV-BALKAR第三階段研究的結果，該研究評估了住院新冠肺炎患者使用巴利替尼加標準治療(SOC)與安慰劑加SOC治療的效果。
- 在參與者進展為無創通氣或在第28天死亡的比例這一主要終點上，該試驗沒有達到統計學意義。
- 接受巴利西尼治療的患者進展為機械通氣(非侵入性或機械性)或死亡的可能性比接受標準護理的患者低2.7%。
- 在SOC的基礎上加用巴利西尼治療(包括79%接受皮質類固醇治療，19%接受瑞希韋治療，有些人同時接受這兩種治療)，使各種原因的死亡率顯著降低38%。
- 巴利西尼治療患者的所有基線嚴重亞組的死亡率均有數字上的降低。在基線水平接受無創機械通氣的患者中這一問題最為明顯(巴利替尼加SOC組與SOC組分別為17.5%和29.4%。
- 巴利西尼組和安慰劑組的不良事件發生頻率大致相似。
- 接受巴利替尼治療的患者中，嚴重感染和靜脈血栓栓塞的發生率分別為8.5%和2.7%，而服用安慰劑的患者分別為9.8%和2.5%。
- 禮來公司打算在未來幾個月內在一份同行評議的期刊上發表這項研究的詳細結果。
- 該公司將與美國、歐盟和其他地區的監管機構分享這項研究的數據，以評估住院的新冠肺炎患者使用巴利替尼的下一步措施。
- 昨天，FDA將巴利替尼治療特應性皮炎的審查期延長了三個月。
- 價格行動：在週四的盤前交易中，Lly股價上漲0.3%，至182.8美元，而INCY股價週三收盤下跌2.2%，至81.38美元。
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
風險及免責聲明
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
風險及免責聲明
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
我知道了
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