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AbbVie's HCV Regimen Okayed for Accelerated Assessment

AbbVie Inc.ABBV recently announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). The drug is now under accelerated assessment for the treatment of all major chronic hepatitis C virus (HCV) genotypes (genotypes 1-6).

Notably, glecaprevir (GLE) is a potent protease inhibitor, while pibrentasvir (PIB) is a new NS5A inhibitor.

The MAA was backed by data from eight registration studies in AbbVie's G/P clinical development program. The clinical studies were conducted on more than 2,300 patients across major HCV genotypes and special populations in 27 countries. Data from the studies showed that eight weeks of treatment with G/P achieved high SVR12 rates across all major genotypes of chronic HCV.

Shares of AbbVie have outperformed the Zacks classified Large Cap Pharma industry in the last six months. The stock lost 6% during the period, while the industry registered a decline of 13.1%.

GLE was discovered through the collaboration between AbbVie and Enanta Pharmaceuticals ENTA for HCV protease inhibitors.

On successful approval, AbbVie's G/P regimen may provide patients with a shorter-duration treatment option. The G/P regimen is expected to be available for marketing in the European Union (EU) in the second half of 2017.

We note that, AbbVie submitted a New Drug Application (NDA) to the FDA for G/P in Dec 2016. AbbVie also remains on track to submit a NDA for G/P in Japan in this quarter.

We remind investors that AbbVie also has an extensive pipeline of several interesting late-stage candidates. Some promising candidates include elagolix (endometriosis and uterine fibroids), atrasentan (chronic kidney disease), veliparib (indications including triple negative breast cancer and previously treated squamous non-small cell lung cancer (NSCLC), and ABT-494 (rheumatoid arthritis, Crohn's disease and ulcerative colitis).

AbbVie Inc. Price

AbbVie Inc. Price | AbbVie Inc. Quote

Zacks Rank & Key Picks

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics, Inc. ANIK and Enzo Biochem, Inc. ENZ . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Anika's earnings estimates increased from $2.09 to $2.10 for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 33.14%.

Enzo Biochem's loss estimates narrowed from 17 cents to 16 cents for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 22.50%.

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Enzo Biochem, Inc. (ENZ): Free Stock Analysis Report

Anika Therapeutics Inc. (ANIK): Free Stock Analysis Report

AbbVie Inc. (ABBV): Free Stock Analysis Report

Enanta Pharmaceuticals, Inc. (ENTA): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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