(Boston Orange 編譯) 羅氏（SIX：
RO，
ROG;OTCQX： RHHBY）6月24日宣佈，歐盟委員會批准了羅氏行銷用於治療復發性多發性硬化症
(RMS)，以及原發進行性多發硬化症
(PPMS) 的皮下注射(SC) OCREVUS®
(奧克麗珠單抗『ocrelizumab』)。
OCREVUS SC是一種10分鐘的注射，和之前批准的靜脈注射法一樣，是一年兩次的療法。全球約有35萬名多發性硬化症患者使用了OCREVUS
IV來治療。
羅氏製藥的醫療長和全球產品發展主管Levi Garraway博士表示，作為這種疾病獲得批准的第一個反CD20療法，OCREVUS改變了多發性硬化症的治療方法。現在歐盟患有多發性硬化症病人可以不需要一個IV場所，一年兩次的在10分鐘之內接受施藥，這使得更多患有多發性硬化症者更容易地獲得治療，同時也節省醫療供應者的時間。
這批準是基於來自OCARINA II第三階段臨床實驗的關鍵數據，顯示了對患有RMS, PPMS來說，當使用皮下注射時，血液中顯示的非不良程度OCREVUS和IV配方的安全及有效性相比，OCREVUS被接受得很好，而且沒有發現新的安全顧慮。作為研究的一部分，接受調查的大約92%的病人表示滿意，或者非常滿意皮下注射OCREVUS。
OCREVUS SC是為一年兩次療法，在IV之外，提供替代選擇而研發出來的方法。所以使用OCREVUS可以和病人及醫療護理專家
(HCPs)的個別需要配合。SC注射是設計為HCP施用的，有著在診所，或者診所外面施用的彈性。羅氏致力促進創新的臨床研究項目，已擴大多發性硬化症的科學了解，進一步減少RMS和PPMS的殘疾進展，並改善罹有多發性硬化症者的治療體驗。
Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis
- OCREVUS subcutaneous (SC) injection offers a new, 10-minute administration of OCREVUS with comparable efficacy and safety to intravenous infusion (IV)
- OCREVUS SC provides an additional treatment option without the need for IV facilities, expanding accessibility for patients
- Roche is working closely with national health systems in Europe to ensure people with multiple sclerosis can access OCREVUS SC as quickly as possible
Basel, 25 June 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion. More than 350,000 people with multiple sclerosis have been treated with OCREVUS IV globally.
“OCREVUS transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease. Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers.”
The approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. OCREVUS SC was well tolerated and no new safety concerns were identified. More than 92% of patients who were surveyed as part of the study reported being satisfied or very satisfied with the SC administration of OCREVUS.
OCREVUS SC was developed to provide an alternative twice-a-year treatment option, in addition to IV, so that the administration of OCREVUS can be matched to the individual needs of patients and healthcare professionals (HCPs). The SC injection was designed to be HCP administered, with the flexibility to administer either in the clinic or in settings outside the clinic. Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of multiple sclerosis, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with multiple sclerosis.
沒有留言:
發佈留言