慢性丙肝组合药物VIEKIRAX+EXVIERA获欧盟批准上市

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2015年1月17日，不到一个月时间内，艾伯维继获美国FDA批准之后，其口服、无干扰素的丙肝药物Viekirax加上Exviera获欧洲委员会批准，对艾伯维而言，无疑是好事连连。
Viekirax (ombitasvir/paritaprevir/ritonavir)和Exviera (dasabuvir)的优势在于口服给药、无需干扰素且疗程较短，Exviera (dasabuvir)在美国的商品名为Viekira Pak。该疗法适用于那些被1型慢性丙型肝炎病毒感染的人群，包括那些并发肝硬化、同时感染HIV-1病毒、使用阿片类药物替代疗法或是肝移植的患者，可以与利巴韦林联用，也可以不用。此外，Viekirax还被批准与利巴韦林联合用药治疗4型丙肝患者。
此次批准是遵照了欧洲药品管理局加速审批的意见，因为欧洲感染慢性HCV的患者大约为900万，这是一个不容小觑的数字。
艾伯维的董事长Richard Gonzalez表示，如此快速的审批通过无疑是为欧洲的患者提供了新的有效治疗方式。同时，这也为艾伯维提供了与吉利德在欧洲丙肝药市场上竞争的机会，目前吉利德的Harvoni与Sovaldi (sofosbuvir)对治疗1型和4型丙肝病毒感染很有优势。
尽管目前吉利德大热的丙肝新药效果极好，但是高昂的价格也是许多患者难以承受的，至少在欧洲就是如此。Gonzalez表示，艾伯维正在与欧洲各国政府与医疗系统合作，争取扩大Viekira + Exviera的使用，其价格优势也是与吉利德竞争的亮点。
重要的欧盟安全信息
禁忌症：
VIEKIRAX+ EXVIERA是禁忌的患者有严重肝损伤（Child-Pugh分级C）。患者服用含有雌二醇乙炔医药产品必须停止它们和以前切换到避孕的另一种方法，以发起VIEKIRAX+ EXVIERA。不要给VIEKIRAX与某些药物是敏感的CYP3A底物或CYP3A的强抑制剂。不要给VIEKIRAX和EXVIERA具有较强的或中等程度的酶诱导剂。不要给EXVIERA与某些药物是CYP2C8的强抑制剂。
特别警告和使用注意事项：
VIEKIRAX和EXVIERA不推荐作为单一疗法，并应在与其它医药产品用于治疗丙型肝炎感染的治疗组合使用。
怀孕和利巴韦林联合应用
当VIEKIRAX+ EXVIERA组合使用利巴韦林，生育能力或他们的男性伴侣的女性一定要在治疗后在治疗6个月期间使用避孕的一种有效形式。是指产品特征的总结利巴韦林了解更多信息。
ALT升高
ALT为>5倍ULN的暂时升高无胆红素升高伴随发生在VIEKIRAX+ EXVIERA临床试验和人谁用乙炔雌二醇含避孕药的亚组更为频繁。
注：以上二种产品可提供，购买请在线咨询：2363244352

European Commission (EC) Grants Marketing Authorizations For AbbVie (ABBV)'s VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) For The Treatment Of Chronic Hepatitis C
NORTH CHICAGO, Ill., Jan. 16, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of VIEKIRAX®(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA®(dasabuvir tablets).1,2 The treatment has been approved with or without ribavirin (RBV) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.1,2 Additionally, VIEKIRAX has been approved for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.1
"The approval of AbbVie's hepatitis C treatment in the European Union, following the recent approvals in the U.S. and Canada, offers patients across Europe a new and effective treatment to cure this serious disease," said Richard Gonzalez, chairman of the board and chief executive officer, AbbVie. "We are committed to working with local governments and healthcare systems to support broad access to VIEKIRAX + EXVIERA." 
The approvals follow a review under accelerated assessment by the European Medicines Agency, designated to new medicines of major public health interest. Approximately nine million people in Europe are infected with chronic hepatitis C, a major cause of liver cancer and liver transplantation.4 Genotype 1 is the most prevalent form of hepatitis C in Europe, accounting for 60 percent of cases worldwide.5 In Europe, the most prevalent sub-genotype is 1b (47 percent).6 Genotype 4, most common in the Middle East, sub-Saharan Africa and Egypt, is becoming increasingly prevalent in several European countries, including Italy, France, Greece and Spain.7 AbbVie's treatment is now licensed for use in all 28 member countries of the European Union, as well as in the U.S., Canada, Switzerland, Iceland, Liechtenstein and Norway.
"Hepatitis C is a complex disease, with multiple genotypes and special patient populations that need to be considered when determining the right treatment for an individual patient," said Stefan Zeuzem, M.D., professor of medicine and chief of the department of medicine I, J.W. Goethe University Hospital, Frankfurt, Germany. "In clinical trials, AbbVie's treatment achieved high cure rates with low rates of discontinuation across a variety of patient populations, making it an important addition to the class of therapies that is changing the way hepatitis C is being treated."
Treating hepatitis C is complex because the virus mutates and replicates rapidly. VIEKIRAX + EXVIERA are the first products to be approved as a combination treatment of three direct-acting antivirals with distinct mechanisms of action and non-overlapping resistance profiles to target hepatitis C at multiple steps in the viral lifecycle.1,2
"With the approval of VIEKIRAX + EXVIERA in the European Union, we are offering a treatment that achieved high cure rates for people living with GT1 and GT4 chronic hepatitis C," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This is an important part of our ongoing commitment to advancing public health by applying innovative science to the development of promising medicines."
Robust Clinical Development Program
The approval of VIEKIRAX + EXVIERA is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries.1,2 The program consisted of six pivotal Phase 3 studies, which demonstrated that VIEKIRAX + EXVIERA cured 95-100 percent of hepatitis C patients with GT1 HCV infection who received the recommended regimen, with less than 2 percent of patients experiencing virologic failure.1,2 Additionally, more than 98 percent (n=2,011/2,053) of patients in clinical trials completed a full course of therapy.3 Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.1,2
The approval of VIEKIRAX + EXVIERA is also based on the results from Phase 2 clinical trials in GT1 chronic HCV infected patients, which showed that VIEKIRAX + EXVIERA cured 97 percent (n=33/34) of liver transplant recipients, 92 percent (n=58/63) of patients co-infected with HIV-1 and 97 percent (n=37/38) of patients on opioid substitution therapy.1,2 Patients who achieve a sustained virologic response (SVR12) are considered cured of hepatitis C.
Approval of VIEKIRAX in GT4 chronic hepatitis C was based on a Phase 2 study in which patients treated with VIEKIRAX with RBV achieved 100 percent SVR12.1
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved for the treatment of genotype 1 chronic hepatitis C virus infection, including patients with compensated cirrhosis. VIEKIRAX consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and EXVIERA consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily taken with or without ribavirin, dosed twice daily. VIEKIRAX + EXVIERA is taken for 12 weeks with or without RBV, except in GT1a patients with cirrhosis, who should take it for 24 weeks.
For the treatment of genotype 4 chronic hepatitis C patients, AbbVie's treatment consists of VIEKIRAX dosed once daily taken with RBV, dosed twice daily.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Additional information about AbbVie's hepatitis C development program can be found on www.clinicaltrials.gov.
EU Indication
VIEKIRAX is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
Important EU Safety Information
Contraindications:
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing medicinal products must discontinue them and switch to an alternative method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong or moderate enzyme inducers. Do not give EXVIERA with certain drugs that are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be used in combination with other medicinal products for the treatment of hepatitis C infection.
Pregnancy and concomitant use with ribavirin
When VIEKIRAX + EXVIERA are used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during the treatment and 6 months after the treatment. Refer to the Summary of Product Characteristics for ribavirin for additional information.
ALT elevations
Transient elevations of ALT to >5x ULN without concomitant elevations of bilirubin occurred in clinical trials with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were using ethinyl estradiol-containing contraceptives.
Use with concomitant medicinal products
Use caution when administering VIEKIRAX with fluticasone or other glucocorticoids that are metabolized by CYP3A4. A reduction in colchicine dosage or interruption in colchicine is recommended in patients with normal renal or hepatic function. VIEKIRAX with or without EXVIERA is expected to increase exposure of statins so certain statins need to be discontinued or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may select for PI resistance in HIV co-infected patients without ongoing antiretroviral therapy. HIV co-infected patients without suppressive antiretroviral therapy should not be treated with VIEKIRAX.
Adverse Reactions
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual country product label for completeinformation.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.