Back-To-Back FDA Approvals For Roche's Two Under-The-Skin Injections
Back-To-Back FDA Approvals For Roche's Two Under-The-Skin Injections
Monday, the FDA approved Roche Holdings AG's (OTC:RHHBY) Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
週一，美國食品和藥物管理局批准了羅氏控股公司（場外交易：RHHBY）的Ocrevus Zunovo（ocrelizumab和透明質酸酶-ocsq）用於複發性多發性硬化（RMS）和初發性進行性多發性硬化（PPMS）。
Ocrevus Zunovo is the first and only twice-a-year healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both forms of multiple sclerosis.
Ocrevus Zunovo是第一個也是唯一一個每年兩次由醫療專業人員（HCP）進行的大約10分鐘皮下注射，可用於治療多種類型的多發性硬化症。
The FDA approval is based on data from the Phase 3 OCARINA 2 trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation in people with RMS and PPMS.
FDA的批准是基於OCARINA 2期臨床試驗的數據，該試驗顯示在皮下注射時Ocrevus的血液水平與靜脈注射的效果相當，並且在患有複發性和初發性進行性多發性硬化症的人群中的安全性和療效與靜脈給藥形式一致。
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In the Phase 2 OCARINA 2 trial, the safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus IV, except for injection reactions.
在OCARINA 2期臨床試驗中，Ocrevus Zunovo的安全性與Ocrevus IV的已知安全性相一致，除了注射反應。
Just on Friday, the FDA also approved Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the U.S.
就在上週五，FDA還批准了羅氏的Tecentriq Hybreza（atezolizumab和hyaluronidase-tqjs），這是第一個也是唯一一個PD-(L)1抑制劑經皮下注射用於美國患者的藥物。
Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).
Tecentriq Hybreza可以在大約七分鐘內皮下注射，而通常的Tecentriq（atezolizumab）靜脈輸注需要30-60分鐘。
It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin, and soft tissue cancer.
它將適用於Tecentriq在美國獲得的所有靜脈途徑適應症，包括某些類型的肺癌、肝癌、皮膚癌和軟組織腫瘤。
The FDA approval is based on Phase 1B/3 IMscin001 study data, which showed comparable levels of Tecentriq in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation.
FDA的批准依據Phase 1B/3 IMscin001研究數據，顯示經皮下給藥與靜脈給藥相比，血中的Tecentriq水平相當，並且具有與靜脈給藥相一致的安全和療效特點。
The Phase 2 IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab.
Phase 2 IMscin002研究顯示，71%的患者更喜歡Tecentriq Hybreza而不是靜脈注射的atezolizumab。
The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (outside the U.S., marketed as Tecentriq SC).
Tecentriq的皮下製劑在2023年8月獲得其首個全球批准，在50個國家（美國以外，市場上稱爲Tecentriq SC）現已獲得批准。
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譯文內容由第三人軟體翻譯。