Gilead Sciences Inc.
) received a boost when the U.S. Food and Drug Administration
(FDA) approved its potential blockbuster drug Sovaldi
(sofosbuvir: once daily) as a combination therapy for treating
patients suffering from chronic hepatitis C virus (HCV),
the primary reason behind liver cancer and liver transplantation
in the U.S. The approval of the all-oral HCV treatment does not
surprise us as its approval was recommended by an advisory panel
of the FDA in Oct 2013. The FDA was scheduled to render its
decision by Dec 8 (target date). The U.S. regulatory body,
however, cleared Sovaldi a couple of days ahead of the scheduled
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Gilead gained U.S. approval for Sovaldi on the basis of
encouraging data from four phase III studies - NEUTRINO, FISSION,
POSITRON and FUSION. Gilead had submitted the new drug
application in April this year. Moreover, the FDA also considered
data from two other phase III studies (VALENCE and PHOTON-1)
after assigning Sovaldi the breakthrough designation status.
The approval of Sovaldi is a ig positive for HCV patients as it
would not only bring down the duration of therapy to a minimum of
12 weeks but would also eliminate/reduce the duration of peg-IFN
injections depending on the genotype of the disease. Currently,
HCV therapy includes up to 48 weeks of treatment with a regimen
inclusive of injectable peg-IFN. Moreover, the current standard
of care comes with several side effects which make it difficult
for patients to remain on treatment.
The FDA cleared the drug after reviewing the application on a
priority basis as an all-oral therapy for treating patients
affected with genotypes 1, 2, 3 or 4 of the virus. Specifically,
the FDA approved Sovaldi combined with ribavirin for treating HCV
patients with genotypes 2 or 3 of the virus, requiring 12 weeks
and 24 weeks of treatment, respectively. The approval of the
Sovaldi containing regimen marks the clearance of the first all
oral treatment for treating chronic HCV patients with genotypes 2
or 3. Sovaldi in combination with ribavirin can also be used to
treat chronic HCV patients awaiting liver transplantation to
prevent the recurrence of the virus after transplant.
Furthermore, the U.S. regulatory body said that Sovaldi in
combination with peg-IFN and ribavirin can be used to treat HCV
patients with genotypes 1 and 4. However, the required treatment
duration is as low as 12 weeks. Gilead stated in its press
release that the wholesaler acquisition cost in the U.S. of a
bottle of Sovaldi containing 28 tablets is $28,000.
The U.S. approval of sofosbuvir would not only boost Gilead's top
line but also strengthen its position in the lucrative HCV
market. Approximately 4 million people are estimated to be
affected by chronic HCV in the U.S. alone. However, the treated
population is much lower. This leaves the field open for new
The FDA approval for Sovaldi comes a few weeks after the
Johnson & Johnson
) Olysio in combination with peg-IFN and ribavirin for treating
chronic HCV patients. Moreover, companies such as
Bristol-Myers Squibb Company
) are developing therapies to combat HCV.
Gilead, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). A better-ranked stock in the biopharma space includes
) which carries a Zacks Rank #1 (Strong Buy).