Gilead Submits New Drug Application to U.S. Food & Drug Administration for the Investigational Single Tablet Regimen Sofosbuv...
December 08 2016 - 8:11AM
Business Wire
- If Approved, SOF/VEL/VOX Would Be the
First Once-Daily Single Tablet Regimen Available as a Salvage
Therapy for Patients Infected with HCV Genotype 1-6 Who Have
Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors
-
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for an investigational, once-daily single
tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg,
and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of
direct-acting antiviral (DAA)-experienced chronic hepatitis C virus
(HCV)-infected patients. The data submitted in the NDA support the
use of the regimen for 12 weeks in DAA-experienced patients with
genotype 1 to 6 HCV infection without cirrhosis or with compensated
cirrhosis.
“The remaining clinical need to treat HCV patients is a safe and
effective cure for patients who have failed previous therapy with
DAA regimens, including those with NS5A inhibitors,” said Norbert
Bischofberger, Ph.D., Executive Vice President of Research and
Development and Chief Scientific Officer at Gilead. “SOF/VEL/VOX
has the potential to fill that need by offering single tablet
dosing and high cure rates across all HCV genotypes for patients
with and without cirrhosis, who have failed prior treatment with
other highly effective regimens.”
The NDA for SOF/VEL/VOX is based on data from two Phase 3
studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the
fixed-dose combination in DAA-experienced patients with hepatitis C
genotypes 1-6, including those who failed prior treatment with an
NS5A-containing regimen. Of the 445 patients treated with
SOF/VEL/VOX, 430 (97 percent) achieved the primary efficacy
endpoint of SVR12. The NDA is further supported by two additional
Phase 3 studies (POLARIS-2 and POLARIS-3) in which 611 DAA-naïve
HCV-infected patients received 8 weeks of SOF/VEL/VOX. The most
common adverse events among patients who received SOF/VEL/VOX were
headache, fatigue, diarrhea and nausea. These data were presented
at the American Association for the Study of Liver Diseases (AASLD)
annual meeting in November 2016.
About SOF/VEL/VOX
The SOF/VEL/VOX fixed-dose combination is an investigational
product and its safety and efficacy have not been established. It
has been granted Breakthrough Therapy designation by the U.S. Food
and Drug Administration for the treatment of chronic genotype 1 HCV
patients who have previously failed an NS5A inhibitor-containing
regimen.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers,
develops and commercializes innovative therapeutics in areas of
unmet medical need. The company’s mission is to advance the care of
patients suffering from life-threatening diseases. Gilead has
operations in more than 30 countries worldwide, with headquarters
in Foster City, California.
Forward-Looking Statement
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that are subject to risks, uncertainties and other factors,
including the risk that the FDA and other regulatory agencies may
not approve the SOF/VEL/VOX fixed-dose combination, and any
marketing approvals, if granted, may have significant limitations
on its use. These risks, uncertainties and other factors could
cause actual results to differ materially from those referred to in
the forward-looking statements. The reader is cautioned not to rely
on these forward-looking statements. These and other risks are
described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2016, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements
are based on information currently available to Gilead, and Gilead
assumes no obligation to update any such forward-looking
statements.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com, follow Gilead on
Twitter (@GileadSciences) or call Gilead Public Affairs at
1-800-GILEAD-5 or 1-650-574-3000.
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