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梯瓦长效版Copaxone拿下欧洲市场,意义重大

  1. 多发性硬化症
  2. 梯瓦
  3. 长效版Copaxone

来源:生物谷 2014-12-08 09:19

长效版Copaxone是梯瓦捍卫其多发性硬化症(MS)专营权的重要筹码,短效Copaxone(每天注射1次)是全球最畅销的MS药物,2013年销售额高达43.3亿美元,位列榜单之首。

2014年12月7日讯 /生物谷BIOON/ --之前,以色列制药巨头梯瓦(Teva)以惊人的速度重新将患者从Copaxone(每天注射1次)成功转向长效版Copaxone(每周注射三次),令行业分析师惊讶不已。

近日,该公司已准备2015年初将长效Copaxone推向欧洲市场。Copaxone(每天注射1次)是全球最畅销的多发性硬化症(MS)药物,该药2013年全球销售额高达43.3亿美元,位列《2013年全球多发性硬化(MS)药物销售TOP10》榜单之首。然而,Copaxone(每天注射1次)专利将于2015年夏天到期,届时该药必将遭受廉价仿制药的巨大冲击。因此,长效版Copaxone在全球主要市场的上市,对梯瓦而言至关重要,将成为捍卫其多发性硬化症(MS)专营权的重要筹码。

本周四,梯瓦宣布长效版Copaxone(每周注射3次)在欧盟分散式审查程序(decentralised approvals procedure)收获了积极结果,欧盟参考成员国英国药品和健康产品管理局(MHRA)和其他欧盟成员国(CMS)已对长效版Copaxone发布了积极评估报告,预计长效版Copaxone将在未来1个月内获欧盟所有成员国批准上市。梯瓦已计划于2015年第一季度首先在德国、荷兰、丹麦推出长效版Copaxone。

在美国,长效版Copaxone(40mg/ml,每周注射3次)于2014年1月获FDA批准,自上市以来,处方患者数已达4万例。与Copaxone(每天注射1次)适应症相同,长效版Copaxone也用于复发型多发性硬化症(RMS)成人患者的治疗。

根据全球领先的制药与医疗保健顾问公司Decision Resources发布的一份报告,未来10年,全球多发性硬化症市场(MS)将以4%的年度复合增长率(CAGR)增长,并在2023年达到200亿美元。(相关阅读:2023年全球多发性硬化症(MS)市场将达200亿美元

报告预测,尽管百健艾迪的口服MS新药Tecfidera将取代梯瓦的Copaxone(每天注射1次)成为市场领导者,但注射型产品仍然是当前重要的治疗方案,同时也是目前MS管线的重要组成部分。在未来,后续长效注射产品将继续取得成功,而梯瓦长效版Copaxone(每周注射3次)将帮助捍卫其多发性硬化症(MS)专营权,并在预测期内实现重磅销售额。(生物谷Bioon.com)

英文原文:Teva Receives Positive Outcome in Europe for Three-Times-a-Week COPAXONE® (Glatiramer Acetate) 40 mg/ml for the Treatment of Relapsing Forms of Multiple Sclerosis (RMS)

MHRA and other EU Member States Issue Positive Assessment Report under the Decentralized Procedure for New, Three-Times-A-Week COPAXONE® 40 mg/ml Formulation

JERUSALEM--(BUSINESS WIRE)--Dec. 4, 2014-- Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that it has received a positive outcome in the decentralized procedure for its new, three-times-a-week COPAXONE® (glatiramer acetate) 40 mg/ml formulation for the treatment of adults with relapsing forms of multiple sclerosis (RMS). The outcome follows a Positive Assessment Report from the United Kingdom, the Reference Member State's Medicines and Healthcare Products Regulatory Agency (MHRA), and all Concerned Member States (CMS) in Europe who were involved in the procedure. Granting of national authorizations will happen in the near future.

The three-times-a-week COPAXONE® 40 mg/ml formulation will allow for an improved, less-frequent, subcutaneous dosing regimen for adults with RMS. The new formulation reduces the total number of injections by almost 60 percent, while maintaining the known benefits of once daily COPAXONE® 20 mg/ml.

"We welcome the opportunity to make COPAXONE® 40 mg/ml available to patients with RMS in Europe," said Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva. "Three-times-a-week COPAXONE® 40 mg/ml will be available in Europe as early as the first quarter of 2015 with expected launches in Germany, Netherlands and Denmark. Launches in other EU countries are expected throughout 2015."

Three-times-a-week COPAXONE® 40 mg/ml was approved by the U.S. Food and Drug Administration in January, 2014 and, since launch, has been prescribed to more than 40,000 patients.

"Teva has been committed to the pursuit of MS research, and the development of COPAXONE®, for more than 20 years," commented Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. "We are proud to be able to bring to patients in Europe the option of this new, three-times-a-week-COPAXONE® 40 mg/ml formulation which we believe will offer patients and their physicians flexibility in choosing a dosing regimen that works best for them."

The RMS's Positive Assessment Report was based primarily on data from the Phase III Glatiramer Acetate Low-Frequency Administration (GALA) study. In the GALA study which included more than 1400 patients, the 40 mg/ml dosage of COPAXONE® administered subcutaneously three times per week significantly reduced relapse rates at 12 months and demonstrated a favorable safety and tolerability profile in patients with RRMS.

Daily COPAXONE® 20 mg/ml, approved in the EU in 2000, continues to be available in Europe.

About COPAXONE®

COPAXONE® (glatiramer acetate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at: www.CopaxonePrescribingInformation.com. For hardcopy releases, please see enclosed full prescribing information. COPAXONE® is now approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.

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