AbbVie Inc. ABBV announced that its regulatory application for the once-daily, fixed-dose formulation of hepatitis C virus (HCV) infection drug, Viekira Pak, has been accepted by the FDA. The agency is expected to render a final decision in the second half of 2016.
The currently available twice-daily Viekira Pak was approved by the FDA late last year for the treatment of patients with chronic HCV genotype 1 infection, including those with cirrhosis, a type of advanced liver disease. The treatment can be used with or without ribavirin but is not recommended for use in patients whose liver is unable to function properly (decompensated cirrhosis). Once-daily Viekira Pak, if approved, could reduce the pill burden on patients and thus, increase patient compliance and convenience. Viekira recorded sales of $1.1 billion in the first nine months of 2015.
We remind investors that in October, Abbvie came under the spotlight after the FDA issued a warning related to Viekira Pak and another HCV drug, Technivie. The agency had stated that both HCV drugs could cause serious liver injury, particularly in patients suffering from underlying advanced liver disease (Read More: AbbVie Slumps, FDA Issues Warning Related to 2 HCV Drugs).
Meanwhile, competition in the HCV market is intensifying. Gilead Sciences’ GILD Sovaldi and Harvoni are already approved for the treatment of this disease, while several companies like Merck & Co. Inc. MRK are looking to bring their own HCV treatments to the market.
AbbVie currently carries a Zacks Rank #3 (Hold). Baxalta Incorporated BXLT and Gilead Sciences are a couple of better-ranked stock in the health care sector. While Baxalta sports Zacks Rank #1 (Strong Buy), Gilead has a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment