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22/11/2014
CHMP grants positive opinions of AbbVie's VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) for the treatment of chronic hepatitis C in Europe

Major regulatory milestone achieved toward approval in the European Union

Final decision from the European Commission expected in the first quarter of 2015

NORTH CHICAGO, Ill., Nov. 21, 2014 -- The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions for AbbVie's (NYSE: ABBV) investigational, all-oral, interferon-free treatment of VIEKIRAX™ (ombitasvir/paritaprevir/ritonavir) + EXVIERA™ (dasabuvir) with or without ribavirin (RBV) for patients with genotype 1 (GT1) and genotype 4 (GT4) chronic hepatitis C virus (HCV) infection. The European Commission will review the opinions and make a final decision sometime in the first quarter of 2015.

"The CHMP positive opinions mark an important milestone in our HCV development program and recognize the potential our treatment brings to people in Europe living with this chronic condition," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Our treatment has been developed with the goal of achieving high cure rates in a broad range of genotype 1 patients with low rates of discontinuation and relapse."

The marketing authorization applications (MAAs) were submitted to the EMA on May 6, 2014 under an accelerated assessment, designated to new medicines of major public health interest. Review of the MAAs is being conducted under the centralized licensing procedure, which if approved will result in marketing authorizations valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

Robust Clinical Program Supported Positive Opinions

The CHMP opinions are supported by a robust clinical development program consisting of six pivotal Phase 3 studies (SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II)1,2,3,4,5 including more than 2,300 GT1 patients in over 25 countries. In addition, the positive opinions were supported by a Phase 2 study, PEARL-I, in GT4 patients without cirrhosis6, as well as preliminary data from the TURQUOISE-I study in GT1 HCV and HIV-1 co-infected patients7 and from the CORAL-I study in liver transplant recipients with recurrent GT1 HCV infection who were new to treatment after transplantation.8

Approximately nine million people in Europe are infected with HCV, which over time may lead to cirrhosis and liver failure in about 10-20 percent of people with chronic HCV.9,10 Genotype 1 is the most common type of HCV genotype9, accounting for 60 percent of cases worldwide.10 In Europe, the most prevalent genotype is 1b (47 percent).11  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.12  

The U.S. Food and Drug Administration (FDA) granted priority review for AbbVie's treatment for patients with GT1 chronic HCV infection on June 13, 2014. AbbVie's treatment was also granted Breakthrough Therapy designation by the FDA, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy.  

About AbbVie's Investigational Chronic HCV Treatment

VIEKIRAX™ + EXVIERA™ is being investigated for the treatment of genotype 1 chronic hepatitis C virus (HCV) 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, with or without ribavirin, dosed twice daily.

AbbVie's chronic HCV treatment combines three direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

For genotype 4 chronic HCV patients, AbbVie's treatment consists of the fixed-dose combination of paritaprevir/ritonavir (150mg/100mg) with ombitasvir (25mg) only, dosed once daily with ribavirin, dosed twice daily.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV 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 hepatitis C.

Additional information about AbbVie's HCV development program can be found on www.clinicaltrials.gov.

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.

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. Feld JJ, Kowdley KV, Coakley E et al. Treatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med. 2014; 370: 1594-1603
2. Zeuzem S, Jacobson IM, Baykal T et al. Retreatment of HCV with ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin. N Engl J Med. 2014; 370:1604-1614
3. Andreone P, Colombo MG, Enejosa JV et al. ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection. Gastroenterology. 2014 Aug;147(2):359-365
4. Ferenci P, Bernstein D, Lalezari J et al. ABT-450/r–Ombitasvir and Dasabuvir with or without Ribavirin for HCV. N Engl J Med. 2014; 370:1983-1992
5. Poordad F, Hezode C, Trinh R et al. ABT-450/r–Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. N Engl J Med. 2014; 370: 1973-1982
6. Pol S, et al. Interferon-Free Regimens of Ombitasvir and ABT-450/r With or Without Ribavirin in Patients With HCV Genotype 4 Infection: PEARL-I Study Results. Hepatology. 2014: vol. 60, no. 4 supplement:1129A
7. Wyles D, Sulkowski M, Eron J, et al. TURQUOISE-I: 94% SVR12 in HCV/HIV-1 co-infected patients treated with ABT-450/r/ombitasvir and dasabuvir and ribavirin. Presented at the 65th Annual Meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2014), November 7–11, 2014, Boston, MA. Poster #1939
8. Kwo P, Mantry P, Coakley E, et al. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014; 1-8. doi: 10.1056/NEJMoa1408921
9. European Association for the Study of the Liver. Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol. 2014; 60: 392-420
10. Global Alert and Response (GAR): Hepatitis C. World Health Organization Web site. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html#HCV. Published 2003. Accessed November 2014 
11. O'Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1. Philadelphia, PA: Saunders Elsevier. 2010:1313-1335
12. Khattab MA, et al. Management of hepatitis C virus genotype 4: Recommendations of an International Expert Panel. J Hepatol. 2011; 54: 1250–1262

 


Source: AbbVie