Abbvie submits for eu marketing authorization its investigational, all-oral, interferon-free therapy for the treatment of chronic hepatitis c – wsfa.com: news weather and sports for montgomery, al.
August 26th, 2014
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SOURCE AbbVie
Submission based on the largest Phase III program in genotype 1 (GT1) hepatitis C patients conducted to date1
European Medicines Agency has granted AbbVie' s request for accelerated assessment
NORTH CHICAGO, Ill., May 8, 2014 /PRNewswire/ AbbVie (NYSE ABBV) submitted marketing authorization applications (MAAs) to the European Medicines Agency (EMA) seeking approval for the company' s investigational, all oral, interferon free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The MAAs are supported by data from the largest all oral, interferon free clinical program in GT1 patients conducted to date1, which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.
“These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all oral, interferon free regimen which has the potential to provide a promising advancement for the hepatitis C community in the European Union,” said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. “This regulatory milestone, on the heels of our submission of a New Drug Application in the U.S., represents an important step for our pipeline.”
Accelerated Assessment Granted
The EMA has granted AbbVie' s request for accelerated assessment for ABT 450/ritonavir, ombitasvir (ABT 267), and dasabuvir (ABT 333), a designation that is granted to new medicines of major public health interest. Review of AbbVie' s MAAs will be conducted under the centralized licensing procedure which, when finalized, provides one marketing authorization in all 28 member states of the European Union (EU). Although accelerated assessment could shorten the EMA' s review time by approximately two months, it does not guarantee a positive opinion from the EMA' s Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, ABT 450/ritonavir, ombitasvir (ABT 267), and dasabuvir (ABT 333) could be available for marketing in the EU in the first quarter of 2015.
Globally, approximately 160 million people are chronically infected with hepatitis C2 and an estimated 3 million to 4 million people are newly infected each year.3 In Europe, approximately 17.5 million people have chronic hepatitis C,4 with GT1 as the predominant genotype.4
About AbbVie' s Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed dose combination of ABT 450/ritonavir (150/100mg) co formulated with ombitasvir (ABT 267) 25mg, dosed once daily, and dasabuvir (ABT 333) 250mg with or without ribavirin (weight based), dosed twice daily. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.
Additional information about AbbVie' s Phase III studies can be found on
AbbVie' s HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon free, all oral regimen with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non responders to interferon based therapy or patients with advanced liver fibrosis or cirrhosis.
ABT 450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ ENTA) for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT 450 is being developed by AbbVie for use in combination with AbbVie' s other investigational medicines for the treatment of hepatitis C.
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 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.
AbbVie undertakes no obligation to release publicly any revisions to forward looking statements as a result of subsequent events or developments, except as required by law.
1 Comparison based on review of data from for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
2 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011 17(2) 107 15.
3 World Gastroenterology Organisation. World Gastroenterology Organisation Global Guidelines Diagnosis, Management and Prevention of Hepatitis C. April 2013. Accessed April 25, 2014.
4 EASL Clinical Practice Guidelines management of hepatitis C virus infection. European Association for the Study of the Liver. J Hepatol. 2014 60 392 420.
© 2012 PR Newswire. All Rights Reserved.
Europa – press releases – press release – europe against cancer : the european commission requests the limitation of tar yield in cigarettes and the inscription of clear medical warnings on the packets of tobacco products
E-cigarettes: second-hand smoke, vaping, and the price of fda regulations hit & run : reason.com
The elimination of all trade barriers by 1992 in the European Community requires the harmonization of national provisions governing the maximum tar yield of cigarettes and the labelling of tobacco products. The concern on people's health must also be accounted for as tobacco is the main cause of mortality through cancer in the European Community. This is the reason why the programme "Europe against Cancer" (O.J. C50 of 26.02.1987) has given priority, with regard to prevention, to the struggle against the abuse of tobacco (see annex I). In this context, and at the initiative of the Vice President Mr. Manuel MARIN, Commissioner responsible of the Programme, the European Commission has just adopted two series of proposals for the attention of the Council of Ministers of the European Community in order to harmonize, before 31 December 1992, legislative, administrative and regulatory national measures concerning the limitation of tar yield in cigarettes and the labelling of tabacco products. With Europe in 1992, a better labelling of tobacco products ... In order to better inform smokers of the risks incurred, the European Commission requests the harmonization of national measures with the Irish model which is the most advanced in the matter (see annex II and pictures of Irish packets of cigarettes). This proposal provides that before the end of 1992 every packet of tobacco products bears the indication "Tobacco seriously damages your health" packets of cigarettes as well as this general health warning should moreover include 2 . a specific message in rotation, to be chosen from a list (see annex III), but which must include one of the two following messages "Smoking causes cancer" and "Smoking causes heart diseases". . tar and nicotine yield. ... and cigarettes less noxious for the health. If every cigarette is noxious for the health, whatever its tar yield, it is however indisputable that the risks of lung cancer are higher if the cigarettes smoked have a high tar yield. Two countries of the European Community already forebade cigarettes with a high tar content Spain (24 mg maximum) and Portugal (28 mg). Experts of the Word Health Organization further recommend the reduction of these limit values to 15 mg. This is why the second proposal requests the harmonization of national measures in this respect in the European Community, establishing as a uniform limit value 15 mg of tar per cigarette before 31 December 1992. Finally, following the recommendations of the Committee of Cancer Experts to the European Commission, it is also recommended to further reduce this limit to 12 mg before the end of 1995. These different proposals should not create adaptation problems for the tobacco industry or retailers. Recent experience shows that manufacturers are able to reduce the tar yield of cigarettes by using better tobaccos, better papers, better filters and a better preparation. As an example, the tar yield of Gauloises varies from 22,8 mg to 5,9 mg (see annex IV). The European Community is conscious of the fact that the limitation of tar yield of cigarettes will pose serious adaptation problems to producers of tobacco varieties with a high tar yield. Therefore, the European Community has already begun to stimulate the adaptation of productions in the more concerned countries of Southern Europe. Thus, within the framework of Common Agricultural Policy or Mediterranean Integrated Programmes, the European Community will reinforce its actions seeking to promote the reorientation towards the production of tobaccos which are less dangerous to health or the reconversion to other productions such as cotton, corn or fruits and vegetables (see annex I). ANNEX I LIST OF 14 MEASURES FOR A CAMPAIGN AGAINST TOBACCO "EUROPE AGAINST CANCER" PROGRAMME Proposed action 1(1) Upwards alignment of taxation on tobacco manufactured in the European Community. Proposed action 2 Financing of preventive actions at national level by the use of increased fiscal measures on tobacco. Action 3(2) Publication of indices excluding tobacco by the Statistical Office of the European Community. Proposed action 4 Harmonization of cigarette labelling in the European Community. Proposed action 5 Prohibition of cigarettes with a high tar content. Proposed action 6 Harmonization of the standards for the components of tobacco smoke. Proposed action 7 Prohibition of tax free sales of tobacco in the European Community. Proposed action 8 Protection of children from tobacco sales. Proposed action 9 Reorientation of tobacco production towards less toxic varieties and study of the possibilities of reconversion. Proposed action 10 Information and public awareness campaign in the struggle against tobacco. Proposed action 11 Study of national provisions and development of proposed Community regulations on tobacco smoking in public places. Proposed action 12 Study of national provisions and development of proposed Community regulations on the limitation of tobacco publicity. Action 13 Comparative analysis of anti smoking campaigns. Action 14 Information exchange in the struggle against smoking (1) These proposed actions will be prepared by the Commission of the European Community and submitted to the European Parliament, for consultation, and to the Council of Ministers of the European Community, for adoption. (2) The actions as stated will be put into effect by the Commission of the European Community using its management powers. ANNEX 3 PROPOSAL FOR A COUNCIL DIRECTIVE ON THE LABELLING OF TOBACCO PRODUCTS List of Health warnings I. Shall be included in the list of warnings to be drawn by Member States a. Smoking causes cancer b. Smoking causes heart desease. II. May be included in the list of warnings to be drawn by the Member States a. Smoking causes fatal deseases b. Smoking can kill you c. Smoking when pregnant can injure your baby and cause premature birth d. Stopping smoking reduces the risk of serious deseases e. Smoking causes lung cancer, bronchitis and other chest deseases f. More than ( ) people die each year in (name of the country) from lung cancer
g. Smokers die younger.
