Johnson & Johnson
) received positive news when the U.S. Food and Drug
Administration (FDA) approved Olysio for hepatitis C
The FDA approved the use of Olysio, a NS3/4A protease
inhibitor, for the treatment of chronic hepatitis C infection.
Olysio is approved as a part of an antiviral treatment regimen in
combination with pegylated interferon and ribavirin in adult
patients suffering from genotype I infection with liver
problems. It can be used in both treatment naïve patients
as well as in patients who have failed prior interferon-based
We note that an approval was on the cards as the Antiviral
Drugs Advisory Committee of the FDA recommended the approval on a
unanimous basis in Oct 2013.
We remind investors that Janssen Therapeutics, a part of
Johnson & Johnson's Janssen Products, submitted its New Drug
Application (NDA) for Olysio to the FDA in Mar 2013.
Subsequently, the FDA granted "priority review" designation to
the NDA in May 2013. Olysio was developed in collaboration with
Medivir AB which holds the marketing rights in Nordic
Johnson & Johnson already has a hepatitis C virus (HCV)
drug in its portfolio - Incivo. The approval of Olysio will
strengthen its HCV franchise. Olysio was approved in Japan under
the trade name, Sovriad, in Sep 2013. It is currently under
review in Europe.
We note that Johnson & Johnson's HCV pipeline recently got
a boost with the acquisition of
) pipeline candidate, GSK2336805.
GSK2336805, a NS5a replication complex inhibitor, is being
developed for the treatment of chronic HCV. Johnson & Johnson
will move the candidate into phase II studies in interferon-free
combinations with its protease inhibitor Olysio and its
non-nucleoside polymerase inhibitor, TMC647055, for the treatment
of chronic HCV in adult patients with compensated liver
As per Johnson & Johnson, as many as 3.2 million people in
the U.S. are infected with HCV. Hence, the market potential for
HCV drugs looks positive but competition is stiff as companies
) are also developing treatments for HCV.
Johnson & Johnson currently carries a Zacks Rank #3
(Hold). Right now, large-cap pharma stock that looks attractive
), with a Zacks Rank #2 (Buy).
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