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AbbVie (ABBV) Submits NDA for Next-Gen HCV Combo in US
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AbbVie Inc. (ABBV - Free Report) announced that it has submitted a New Drug Application (NDA) to the FDA for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). The combination drug is being assessed for the treatment of chronic hepatitis C virus (HCV).
AbbVie’s share price has gained 3% in the past one month, outperforming the 1.4% gain witnessed by the Zacks classified Large-Cap Pharmaceuticals industry.
Coming back to latest news, Glecaprevir (GLE) is a potent protease inhibitor while pibrentasvir (PIB) is a new NS5A inhibitor.
The NDA is supported by data from eight registration studies in AbbVie's G/P clinical development program. The phase III clinical studies were conducted on more than 2,300 patients in 27 countries across major HCV genotypes and special populations.
Last month, AbbVie presented data from the studies, which showed that eight weeks of treatment with G/P achieved high SVR12 rates across all major genotypes of chronic HCV.
The data presented from 8-week arms of three registrational clinical studies showed that 97.5%% of chronic HCV infected patients without cirrhosis and who are new to treatment across all major genotypes (GT1-6) achieved SVR12 with 8 weeks of G/P treatment. . Whereas, in patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. The studies also showed that high SVR rates were achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD). For patients that cannot be cured by prior direct-acting antiviral (DAA) treatment, high SVR rates were achieved in less than 12 weeks.
In September this year, FDA granted Breakthrough Therapy designation for G/P for the treatment of HCV in patients who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including treatment with an NS5A inhibitor and/or protease inhibitor. The breakthrough therapy status for pan-genotypic regimen was granted on the basis of positive results from the phase II MAGELLAN-1 clinical study.
AbbVie currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Cambrex Corporation , Heska Corporation and Anika Therapeutics Inc (ANIK - Free Report) . While Cambrex and Heska sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 83.8% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 5.2% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 13% year to date.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up 9.2% and 3.4%, respectively in the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price is up 26.4% year to date.
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AbbVie (ABBV) Submits NDA for Next-Gen HCV Combo in US
AbbVie Inc. (ABBV - Free Report) announced that it has submitted a New Drug Application (NDA) to the FDA for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P). The combination drug is being assessed for the treatment of chronic hepatitis C virus (HCV).
AbbVie’s share price has gained 3% in the past one month, outperforming the 1.4% gain witnessed by the Zacks classified Large-Cap Pharmaceuticals industry.
Coming back to latest news, Glecaprevir (GLE) is a potent protease inhibitor while pibrentasvir (PIB) is a new NS5A inhibitor.
The NDA is supported by data from eight registration studies in AbbVie's G/P clinical development program. The phase III clinical studies were conducted on more than 2,300 patients in 27 countries across major HCV genotypes and special populations.
Last month, AbbVie presented data from the studies, which showed that eight weeks of treatment with G/P achieved high SVR12 rates across all major genotypes of chronic HCV.
The data presented from 8-week arms of three registrational clinical studies showed that 97.5%% of chronic HCV infected patients without cirrhosis and who are new to treatment across all major genotypes (GT1-6) achieved SVR12 with 8 weeks of G/P treatment. . Whereas, in patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. The studies also showed that high SVR rates were achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD). For patients that cannot be cured by prior direct-acting antiviral (DAA) treatment, high SVR rates were achieved in less than 12 weeks.
In September this year, FDA granted Breakthrough Therapy designation for G/P for the treatment of HCV in patients who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including treatment with an NS5A inhibitor and/or protease inhibitor. The breakthrough therapy status for pan-genotypic regimen was granted on the basis of positive results from the phase II MAGELLAN-1 clinical study.
ABBVIE INC Price
ABBVIE INC Price | ABBVIE INC Quote
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Cambrex Corporation , Heska Corporation and Anika Therapeutics Inc (ANIK - Free Report) . While Cambrex and Heska sport a Zacks Rank #1 (Strong Buy), Anika carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 in the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 83.8% year to date.
Cambrex’s earnings estimates increased 3.7% for 2016 and 5.2% for 2017 in the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 13% year to date.
Anika Therapeutics’ earnings estimates for 2016 and 2017 were up 9.2% and 3.4%, respectively in the last 60 days. The company has recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price is up 26.4% year to date.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>