FDA Clears Gilead's Sovaldi - Analyst Blog
09 Dezember 2013 - 11:00PM
Zacks
Gilead Sciences
Inc. (GILD) 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 target date.
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 treatments.
The FDA approval for Sovaldi comes a few weeks after the clearance
of Johnson & Johnson’s (JNJ) Olysio in
combination with peg-IFN and ribavirin for treating chronic HCV
patients. Moreover, companies such as Bristol-Myers Squibb
Company (BMY) 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
Actelion Ltd. (ALIOF) which carries a Zacks Rank
#1 (Strong Buy).
ACTELION LTD (ALIOF): Get Free Report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
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