AbbVie (ABBV) Gets FDA Nod For Label Expansion Of HCV Drug

AbbVie Inc. (NYSE:ABBV) announced that the FDA approved the label expansion of Mavyret (glecaprevir/pibrentasvir). The agency approved the drug to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all genotypes (GT1-6). The drug is meant to treat adults and children aged 12 years or older. Following this approval, HCV patients can be treated within 8 weeks.

The label expansion was supported by data from the phase EXPEDITION-8 study, evaluating the safety and efficacy of Mavyret in treatment-naive adults with GT1-6 chronic HCV and compensated cirrhosis. In the study, an overall 98% of patients achieved a sustained virologic response 12 weeks after treatment (SVR₁₂).

Mavyret is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed as three tablets taken at the same time once daily with food. Notably, the drug received regulatory approval in the United States in August 2017, as an 8-week, pan-genotypic treatment in treatment-naive HCV patients without cirrhosis.

Shares of the company have lost 19.8% year to date compared with the industry’s decline of 0.6%.

HCV is a disease that causes inflammation of the liver, which can lead to diminished liver functions or liver failure. There are more than 2.3 million people in the United States still living with chronic HCV. Both Gilead Sciences Inc. (NASDAQ:GILD) and Merck & Co. (NYSE:MRK) have HCV drugs in their portfolio.

Zacks Rank and A Stock to Consider

AbbVie currently has a Zacks Rank #3 (Hold).

A better-ranked stock in the large-cap pharmaceutical sector is Novartis (NYSE:NVS) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Novartis’ earnings per share estimates increased from $5.06 to $5.15 for 2019 and from $5.71 to $5.77 for 2020 over the past 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters, the average beat being 2.84%.

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