Europe Drug Regulator's Advising Panel Recommends Approval Of Novo Nordisk's Australia-Approved Hemophilia Drug
Europe Drug Regulator's Advising Panel Recommends Approval Of Novo Nordisk's Australia-Approved Hemophilia Drug
Alhemo is an anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody that, if approved by the European Commission, will offer the first once-daily subcutaneous prophylactic treatment to people with hemophilia A or B with inhibitors.On Friday, Novo Nordisk A/S (NYSE:NVO) said that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending approval of Alhemo (concizumab) as the first once-daily subcutaneous prophylactic treatment for hemophilia patients aged 12 years or older, with A or B with inhibitors.
週五，Novo Nordisk A/S（紐交所：NVO）表示，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）通過了一個積極的意見，推薦批准Alhemo（concizumab）作爲首個一日一次皮下預防治療血友病患者的藥物，適用於12歲及以上的A或b抗體制劑。
Haemophilia is a rare bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding.
血友病是一種罕見的出血性疾病，會影響身體制止出血所需的凝血過程。
Also Read: Novo Nordisk's Hemophilia Candidate Can Prevent Bleeding Episodes Effectively, Regardless Of Dosing Frequency.
另請閱讀：諾和諾德的血友病候選藥物能有效預防出血事件，無論用藥頻率如何。
Alhemo is an anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody that, if approved by the European Commission, will offer the first once-daily subcutaneous prophylactic treatment to people with hemophilia A or B with inhibitors.
Alhemo是一種抗組織因子通路抑制劑（TFPI）抗體，如果獲得歐洲委員會批准，將爲血友病A或b抗體制劑的患者提供首個一日一次皮下預防治療。
Alhemo is designed to block a protein called TFPI in the body that stops blood from clotting.
Alhemo旨在阻斷體內的一種名爲TFPI的蛋白質，該蛋白質會阻止血液凝結。
By blocking TFPI, Alhemo ensures the production of thrombin, which helps to clot the blood and prevent bleeding, even when the other clotting factors are missing or deficient.
通過阻斷TFPI，Alhemo確保了凝血酶的產生，從而有助於血液凝結和預防出血，即使其他凝血因子缺失或不足。
The CHMP positive opinion is based on phase 3 explorer7 study data.
CHMP的積極意見基於第三期explorer7研究數據。
The results showed an 86% reduction in treated spontaneous and traumatic bleeds when on concizumab prophylaxis, with an estimated mean annualized bleeding rate (ABR) of 1.7 compared to 11.8 with no prophylaxis.
結果顯示，在concizumab預防治療期間，治療自發性和創傷性出血減少了86％，估計的年均出血率（ABR）爲1.7，而無預防治療時爲11.8。
The overall median ABR of concizumab was zero, compared to 9.8 for no prophylaxis.
concizumab的整體中位數ABR爲零，而無預防措施的ABR爲9.8。
If approved, Alhemo will be provided in a portable, pre-mixed, and prefilled pen, enabling quick and easy subcutaneous administration.
如果獲得批准，Alhemo將以便攜式、預混合和預填充筆的形式提供，便於快速和簡便皮下注射。
Novo Nordisk expects a final approval by the European Commission within approximately two months.
諾和諾德預計歐洲委員會將在大約兩個月內最終批准。
Alhemo is currently approved in Australia and Switzerland for adolescents and adults with hemophilia A or B with inhibitors.
Alhemo目前在澳大利亞和瑞士獲得批准，適用於青少年和成人，患有血友病A或B並存在抗體。
In Japan, Alhemo is currently approved for adolescents and adults with hemophilia A or B with and without inhibitors and is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
在日本，Alhemo目前已批准供應給血友病A或B並存在或不存在抗體的青少年和成人，指示爲常規預防以預防或減少出血發作的頻率。
In June, Novo Nordisk acquired the Hemophilia A program and rights to 2seventy Bio Inc's (NASDAQ:TSVT) in vivo gene editing technology outside of oncology and gene editing for autologous or allogeneic cell therapies of immune cells for autoimmune disease.
6月，諾和諾德收購了血友病A項目以及2seventy Bio Inc的（納斯達克:TSVT）體內基因編輯技術，涉及腫瘤學以外的基因編輯和用於自體或異體細胞治療自身免疫性疾病。
Price Action: NVO stock is down 0.34% at $117.82 at last check Friday.
股價走勢：NVO股價下跌0.34%，報117.82美元，在上週五最新數據時檢查。
Image via Shutterstock
圖片來自shutterstock。
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譯文內容由第三人軟體翻譯。
