AbbVie Submits New Drug Application to U.S. FDA for its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Hepatitis C

-Submission based on the largest Phase III program in genotype 1 (GT1) hepatitis C patients conducted to date(1)

-AbbVie's investigational regimen was designated as a Breakthrough Therapy by the FDA

-AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May

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Apr 22, 2014, 08:46 ET

NORTH CHICAGO, Ill., April 22, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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 NDA is supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date,¹ with six Phase III studies that included more than 2,300 patients in over 25 countries.

"This NDA submission is a significant advancement for AbbVie's HCV development program," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "Based on the robust data that have been generated in our international Phase III HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection."

In May of 2013, AbbVie's investigational direct-acting antiviral (DAA) regimen with and without ribavirin for HCV genotype 1 was designated as a Breakthrough Therapy by the U.S. FDA. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating a drug or regimen may have substantial improvement on at least one clinically significant endpoint compared to available therapy.

AbbVie plans to submit applications for regulatory approval of its regimen in the European Union in early May.

In the U.S., an estimated 3.2 million people are living with HCV and the infection is most prevalent among those born between 1945 and 1965.²

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 RBV (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 www.clinicaltrials.gov.

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 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 Comparison based on review of data from www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.

² Centers for Disease Control and Prevention. Hepatitis C FAQs for Health Professionals. 2013. http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm#section1. Accessed March 14, 2014.

SOURCE AbbVie