AbbVie (ABBV, Financial) announced today through PRNewswire that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for its “investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P).”
The glecaprevir/pibrentasvir (G/P) regimen has been assessed on patients infected with chronic hepatitis C that have suffered kidney damage.
The application is backed by encouraging results collected by trials undertaken worldwide on over 2,300 patients affected with the main genotypes of hepatitis C.
From a previous registrational study in which 711 noncirrhotic patients infected by genotypes 1-6 of the hepatitis C virus were treated for eight weeks with the G/P regimen, 97.5% of these patients “achieved sustained virologic response at 12 weeks post treatment (SVR-12), regardless of baseline viral load,” AbbVie said. These patients did not show any significant adverse events during the treatment.
The RNA of hepatitis C was undetectable 12 weeks after the treatment with the G/P regimen in the blood serum of asymptomatic cirrhotic patients affected with hepatitis C virus, and in the blood serum of 102 out of 104 (98%) of those patients infected with chronic hepatitis C and suffered renal damage.
The second category of hepatitis C patients are characterized to have “limited treatment options,” the company said.
The company said if the drug is approved, "G/P will provide an eight week once-daily, ribavirin-free treatment option for HCV patients without cirrhosis across all major genotypes”.
AbbVie is working to have its marketing application filed in Europe in the first quarter of 2017.
AbbVie is a member of the Standard & Poor's 500.
AbbVie is trading at $62.63, up 42 cents per share or 0.69% from the previous trading day. The 52-week range is between $50.71 per share and $68.12 per share.
A volume of 5,610,308 shares have been traded on the New York Stock Exchange since the market opened versus an average volume of 7.63 million shares over the last three months.
The stock is more volatile than the stock market (beta = 1.52) and underperformed the S&P 500 by 5.12%Â year to date.
AbbVie has a market capitalization of $101.78 billion and has 1.63 billion shares outstanding. The percentage of shares held by insiders is 0.10% and by institutions is 73.60%.
The number of shares available for trading is 1.62 billion. The price-earnings (P/E) ratio (TTM) is 16.93, the EPS (TTM) is $3.7 per share, the dividend yield is 4.13% and the payout ratio is 60%.
The company has approximately $7.95 billion of cash on hand, or $4.89 per share. The total debt (mrq) is $37.31 billion and the book value per share (mrq) is $3.98.
In the third quarter, NWQ Managers (Trades, Portfolio), Joel Greenblatt (Trades, Portfolio), David Dreman (Trades, Portfolio), Mario Gabelli (Trades, Portfolio) and Ken Fisher (Trades, Portfolio) reduced their positions in AbbVie by 73.90%, 24.43%, 5.52%, 42.78% and 1.35%.
Disclosure: I have no positions in AbbVie Inc.
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