AbbVie Submits New Drug Application to U.S. FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

NORTH CHICAGO, Ill., Dec. 19, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the company's investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of chronic hepatitis C virus (HCV). In Phase 3 clinical studies, eight weeks of therapy with G/P achieved high sustained virologic response (SVR) rates across all major genotypes (GT 1-6) in patients without cirrhosis, which represents the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD). In historically difficult to treat populations, including those not cured* by prior direct-acting antiviral (DAA) treatment regimens, high SVR rates were achieved with durations as short as 12 weeks.

"Our regimen of glecaprevir and pibrentasvir shows promise for patients by achieving high cure rates in Phase 3 clinical studies across all major hepatitis C genotypes," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "We look forward to working with the FDA as they review our New Drug Application, which we believe represents another important step toward a faster path to virologic cure for hepatitis C patients."

The NDA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across major HCV genotypes and special populations. Patient populations studied included genotypes 1-6, those new and experienced to treatment, those with compensated cirrhosis and without cirrhosis and patients with specific treatment challenges, including those with severe CKD, and those not cured with a prior DAA containing regimen.

AbbVie previously announced registrational data that demonstrated with eight weeks of treatment 97.5 percent (n=693/711) of chronic HCV GT1-6 patients without cirrhosis and new to treatment achieved sustained virologic response at 12 weeks post treatment (SVR₁₂). Additional data submitted show that with 12 weeks of treatment 98 percent (n=102/104) of severe CKD patients achieved SVR₁₂ in a primary intent-to-treat (ITT) analysis. In a modified intent-to-treat (mITT) analysis of severe CKD patients, 100 percent (n=102/102) of patients achieved SVR₁₂. The mITT analysis excludes patients who did not achieve SVR for reasons other than virologic failure. The most commonly reported adverse events (AEs) for severe CKD patients were pruritus, fatigue and nausea. The most commonly reported AEs for GT1-6 patients without cirrhosis and new to treatment were headache and fatigue. These data were presented at The American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2016. Data for other registrational studies will be shared in future meetings.          

On September 30, 2016, AbbVie announced that the FDA granted Breakthrough Therapy Designation (BTD) for G/P for the treatment of patients with HCV who were not cured with prior DAA therapy in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor. The BTD is supported by positive results seen in AbbVie's Phase 2 MAGELLAN-1 clinical study. According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.¹

Additional information on the clinical trials for G/P is available at www.clinicaltrials.gov.

*Patients with a sustained virologic response at 12 weeks post treatment (SVR₁₂) are considered cured of hepatitis C.

About AbbVie's HCV Clinical Development Program 
AbbVie's glecaprevir/pibrentasvir (G/P) clinical development program was designed to investigate a faster path to virologic cure* for all major HCV genotypes (GT1-6) and with the goal of addressing treatment areas of continued unmet need.

G/P is an investigational, pan-genotypic regimen that is being evaluated as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, who make up the majority of HCV patients. AbbVie is also studying G/P in patients with specific treatment challenges, such as genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

G/P is a once-daily regimen that combines two distinct antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. G/P is dosed once-daily as three oral tablets.

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.

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. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 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," of AbbVie's 2015 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 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed November 23, 2016.

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SOURCE AbbVie