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AstraZeneca/Amgen's Asthma Drug Aces Late-Stage Study In Patients With Chronic Rhinosinusitis

AstraZeneca/Amgen's Asthma Drug Aces Late-Stage Study In Patients With Chronic Rhinosinusitis

阿斯利康/安進的哮喘藥在慢性鼻竇炎患者的晚期研究中取得優異成績
Benzinga ·  11/08 21:47

AstraZeneca Plc (NASDAQ:AZN) and Amgen Inc (NASDAQ:AMGN) released topline data from the Phase 3 WAYPOINT trial of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps])

阿斯利康(NASDAQ:AZN)和安進公司(NASDAQ:AMGN)發佈了Tezspire(tezepelumab)第3期WAYPOINT試驗在慢性鼻竇炎伴有鼻息肉(CRSwNP [鼻息肉])患者的上線數據

The data showed that Tezspire demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.

數據顯示,Tezspire相對安慰劑在鼻息肉大小和鼻塞減輕方面表現出顯著的統計學意義和臨床意義

Also Read: Amgen/AstraZeneca's Asthma Drug Tezspire Vs. Sanofi/Regeneron's Blockbuster Dupixent – Analyst Gives His Pick

另請閱讀:安進/阿斯利康的哮喘藥Tezspire與賽諾菲/再升公司的暢銷藥Dupixent對比 - 分析師給出他的選擇

WAYPOINT is a randomized, double-blind trial that evaluated the efficacy and safety of Tezspire administered subcutaneously compared to placebo in adults with severe CRSwNP.

WAYPOINT是一項隨機、雙盲試驗,評估了皮下注射給藥的Tezspire相對於安慰劑在重度CRSwNP成人患者中的療效和安全性

Participants in the trial were symptomatic despite treatment with standard of care (intranasal corticosteroids [INCS]).

儘管接受標準治療(鼻內皮質類固醇[INCS])仍有症狀的研究參與者

Chronic rhinosinusitis with nasal polyps is a condition that can cause symptoms from sinus pain and nose stuffiness to loss of smell. Nasal polyps are growths in the nose or sinuses.

慢性鼻竇炎伴有鼻息肉是一種可以引起鼻竇疼痛、鼻塞甚至嗅覺喪失的疾病。鼻息肉是鼻腔或鼻竇的生長物

The safety profile and tolerability of Tezspire in this trial were consistent with the known profile of the medicine.

此試驗中Tezspire的安全性和耐受性與這種藥物的已知特點一致

Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.

完整結果將在即將舉行的醫學會議上與監管機構和科學界分享

Tezspire is currently approved for severe asthma in the US, EU, Japan, and nearly 60 countries.

Tezspire目前已在美國、歐盟、日本和近60個國家批准用於治療嚴重哮喘。

It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.

它已在美國和歐盟獲批作爲一次性預裝注射器和自動注射器進行自我管理。

In May, the companies announced the results of the Phase 2a COURSE trial of Tezspire for severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) irrespective of emphysema, chronic bronchitis, or smoking status.

5月,這些公司宣佈了針對嚴重慢性阻塞性肺疾病(COPD)的Tezspire的2a期COURSE試驗結果,該試驗涵蓋了基線血嗜酸性粒細胞計數(BEC)的廣泛範圍,不考慮有無肺氣腫、慢性支氣管炎或吸菸狀況。

The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant.

主要結果顯示,與52周的安慰劑相比,Tezspire治療導致嚴重或中度COPD惡化年發作率減少了17%,但這在統計學上不顯著。

Price Action: AMGN stock closed at $321.91 on Thursday, and AZN stock is up 0.11% at $64.76 during the premarket session at the last check on Friday.

股價走勢:AMGN股價週四收盤價爲321.91美元,AZN股價在週五最後檢查時的盤前交易中上漲了0.11%,報64.76美元。

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譯文內容由第三人軟體翻譯。


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