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).
周一，美国食品和药物管理局批准了罗氏控股公司（场外交易：RHHBY）的Ocrevus Zunovo（ocrelizumab和透明质酸酶-ocsq）用于复发性多发性硬化（RMS）和初发性进行性多发性硬化（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是第一个也是唯一一个每年两次由医疗专业人员（HCP）进行的大约10分钟皮下注射，可用于治疗多种类型的多发性硬化症。
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的批准是基于OCARINA 2期临床试验的数据，该试验显示在皮下注射时Ocrevus的血液水平与静脉注射的效果相当，并且在患有复发性和初发性进行性多发性硬化症的人群中的安全性和疗效与静脉给药形式一致。
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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期临床试验中，Ocrevus Zunovo的安全性与Ocrevus IV的已知安全性相一致，除了注射反应。
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.
就在上周五，FDA还批准了罗氏的Tecentriq Hybreza（atezolizumab和hyaluronidase-tqjs），这是第一个也是唯一一个PD-(L)1抑制剂经皮下注射用于美国患者的药物。
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可以在大约七分钟内皮下注射，而通常的Tecentriq（atezolizumab）静脉输注需要30-60分钟。
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.
它将适用于Tecentriq在美国获得的所有静脉途径适应症，包括某些类型的肺癌、肝癌、皮肤癌和软组织肿瘤。
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的批准依据Phase 1B/3 IMscin001研究数据，显示经皮下给药与静脉给药相比，血中的Tecentriq水平相当，并且具有与静脉给药相一致的安全和疗效特点。
The Phase 2 IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab.
Phase 2 IMscin002研究显示，71%的患者更喜欢Tecentriq Hybreza而不是静脉注射的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的皮下制剂在2023年8月获得其首个全球批准，在50个国家（美国以外，市场上称为Tecentriq SC）现已获得批准。
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