UK Approves Merck's Hypertension Drug Acquired Via $11 Billion Acceleron Pharma Deal
UK Approves Merck's Hypertension Drug Acquired Via $11 Billion Acceleron Pharma Deal
Last Friday, the Medicines and Healthcare Products Regulatory Agency approved Merck & Co Inc's (NYSE:MRK) Winrevair (sotatercept) for adult patients with pulmonary arterial hypertension (PAH).
上週五，藥品和保健產品管理局批准了默沙東（紐交所：MRK）針對成年肺動脈高壓（PAH）患者的Winrevair（sotatercept）。
Sotatercept is used, in combination with other medicines, to treat PAH in adults with moderate or marked physical activity limitations and improve exercise capacity.
Sotatercept與其他藥物聯合使用，治療體力活動限制中度或明顯的成年人肺動脈高壓（PAH），並改善運動能力。
The recommended dosing schedule is one injection every three weeks via self-administration.
推薦的劑量計劃是每三週自我注射一次。
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In March 2024, the FDA approved Winrevair (sotatercept-csrk), for injection, 45mg, 60mg for adults with PAH to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events.
2024年3月，FDA批准了Winrevair（sotatercept-csrk）注射劑，45mg、60mg用於具有肺動脈高壓（PAH）的成年人，以提高運動能力、改善WHO功能分類並降低臨牀惡化事件的風險。
A main study was conducted involving 323 patients with PAH. The study showed that sotatercept was more effective than placebo at improving the ability of adults with PAH to exercise. The main measure of effectiveness was the difference in the distance patients could walk in 6 minutes before and after treatment.
一項主要研究涉及323名肺動脈高壓患者。研究顯示，sotatercept在改善肺動脈高壓成年人運動能力方面比安慰劑更有效。有效性主要測量是治療前後患者在6分鐘內行走的距離差異。
After 24 weeks of treatment, sotatercept given in addition to other PAH medicines, improved the distance patients could walk in 6 minutes by around 34 meters, compared with 1 meter in patients who received a placebo instead. The median (average) treatment difference between the sotatercept and placebo groups was 40.8 meters.
經過24周的治療，sotatercept與其他PAH藥物一起使用，使患者在6分鐘內行走的距離提高了約34米，而接受安慰劑的患者只有1米。sotatercept與安慰劑組之間的中位治療差異爲40.8米。
In November, Merck revealed topline results from the Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality.
11月，默沙東公佈了評估Winrevair（sotatercept-csrk）在高風險死亡的肺動脈高壓（PAH，WHO第1組）功能分類（FC）III或IV成年人中的第三階段ZENITH研究的頂線結果。
ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours).
ZENITH達到了其主要終點，即首次發病或死亡事件的時間（所有原因導致的死亡、肺移植或與PAH惡化相關的住院治療≥24小時）。
Price Action: MRK stock is up 0.56% at $100.04 at last check Thursday.
價格動態：默沙東股票在週四的最後交易中上漲0.56%，報100.04美元。
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Image via Merck
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譯文內容由第三人軟體翻譯。
