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AbbVie's HCV Combo Drug Gets Positive CHMP Opinion in EU


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AbbVie Inc. ABBV announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval of its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P).

The combination medicine is currently under accelerated assessment in the EU and priority review in the U.S. and Japan for the treatment of all major chronic hepatitis C virus (HCV) genotypes (genotypes 1-6) with commercialization expected this year.

The candidate will be marketed by the trade name of Maviret. A decision from the European Commission is expected in the third quarter of 2017.

If approved, the G/P regimen will provide patients with a shorter-duration eight week, once-daily, ribavirin-free treatment option.

So far this year, AbbVie's share price has increased 16.1%, comparing favorably with a gain of 15% recorded by the Zacks classified Large-Cap Pharma industry.

Coming back to the latest news, Glecaprevir (GLE) is a potent protease inhibitor while pibrentasvir (PIB) is a new NS5A inhibitor. Glecaprevir was discovered under a collaboration agreement between AbbVie and Enanta Pharmaceuticals ENTA for HCV protease inhibitors.

The Marketing Authorization Application (MAA) in the EU 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.

We remind investors that Gilead Sciences, Inc. GILD launched Epclusa, the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 HCV infection, in the U.S. and EU last year. This could pose strong competition to AbbVie's next-generation HCV combo therapy, if approved.

Meanwhile, Merck & Co., Inc. MRK is also evaluating an all-oral triple combination therapy MK-3682B, a combination of MK-3682, grazoprevir and ruzasvir1, for the treatment of chronic HCV genotype (GT) infection. The candidate has also resulted in high SVR12 rates in GT1, GT2 and GT3-infected patients, who received the combination therapy for 12 or 16 weeks.

AbbVie carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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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.





This article appears in: Investing , Business , Stocks
Referenced Symbols: MRK , ABBV , GILD , ENTA



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