-- Vosevi is the First and Only Single
Tablet Regimen for Patients Who Have Previously Failed Therapy with
Direct-Acting Antivirals --
-- European Commission Also Extends
Marketing Authorization for Harvoni®
(sofosbuvir/ledipasvir), Enabling First Direct-Acting Antiviral
Regimen for Adolescent Hepatitis C Patients --
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the
European Commission has granted marketing authorization for Vosevi®
(sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), as a
once-daily single tablet regimen for the treatment of adults with
genotype 1-6 chronic hepatitis C virus (HCV) infection.
Vosevi was authorized as a 12-week treatment regimen for
patients with any genotype of chronic HCV infection, without
cirrhosis or with compensated cirrhosis, who have previously failed
therapy with a direct-acting antiviral (DAA)-containing regimen. A
12-week regimen was also authorized for use in DAA-naïve patients
with compensated cirrhosis infected with any HCV genotype, with an
option to shorten therapy to 8 weeks for those infected with
genotype 3. For DAA-naïve patients without cirrhosis, the
recommended treatment duration is 8 weeks.
“DAA-based therapies have transformed our ability to treat
hepatitis C. However, until now we have had limited options for
patients who have failed to achieve cure with these regimens,” said
Professor Michael Manns, Director of the Department of
Gastroenterology, Hepatology and Endocrinology, Hannover Medical
School, Hannover, Germany. “Vosevi has demonstrated high cure rates
across a range of DAA-experienced patients, with a simple 12-week
single tablet regimen. Availability of Vosevi will have a
significant impact for this group of patients, offering them the
opportunity to be cured of this disease.”
Gilead also today announced an extension of the marketing
authorization for Harvoni® (ledipasvir 90mg/sofosbuvir 400mg).
Previously authorized for the treatment of adults with chronic HCV
genotype 1, 3, 4, 5 or 6 infection, the indication for Harvoni has
been extended to include the treatment of chronic HCV genotype 1,
3, 4, 5 and 6 infection in adolescents aged 12 to < 18 years.
Harvoni is the first direct-acting antiviral regimen to receive
marketing authorization in the European Union extended for use in
the adolescent population.
“The authorization of Vosevi and the extended indication for
Harvoni demonstrate our ongoing commitment to bring therapies with
high cure rates to all HCV-infected patients,” said John Milligan,
PhD, Gilead’s President and Chief Executive Officer. “We look
forward to working with healthcare providers and governments to
ensure Vosevi is made available to patients who would benefit the
most from it, while continuing to expand the benefits of our other
approved medicines for patients with chronic HCV infection across
Europe.”
Sofosbuvir-based regimens are recommended by global guidelines
across HCV genotypes and disease severities and have been used to
treat more than 1.5 million patients worldwide. Vosevi is Gilead’s
fourth sofosbuvir-based treatment to be granted marketing
authorization by the European Commission for the treatment of
chronic HCV infection. The marketing authorization of Vosevi
follows an accelerated review procedure by the European Medicines
Agency, reserved for medicinal products expected to be of major
public health interest. It allows for the marketing of Vosevi in
all 28 countries of the European Union. Gilead will now work
diligently with national pricing and reimbursement agencies across
Europe to make Vosevi available to patients.
The approval of Vosevi is supported by data from four Phase 3
studies. Two studies (POLARIS-1 and POLARIS-4) evaluated 12 weeks
of the single tablet regimen in patients with hepatitis C genotypes
1-6 previously treated unsuccessfully with DAA-containing regimens,
including NS5A inhibitors. Two other studies (POLARIS-2 and
POLARIS-3) evaluated 8 weeks of Vosevi in DAA-naïve patients with
hepatitis C genotypes 1-6. Across POLARIS-1 and POLARIS-4, 97
percent of patients treated with Vosevi (n=431/445) achieved the
primary efficacy endpoint of SVR12. In POLARIS-2, 95 percent of
patients with hepatitis C genotypes 1-6 with and without cirrhosis
treated with Vosevi (n=477/501) achieved the primary efficacy
endpoint of SVR12. In POLARIS-3, 96 percent of patients with
genotype 3 infection and compensated cirrhosis treated with Vosevi
(n=106/110) achieved the primary efficacy endpoint of SVR12. The
most common adverse drug reactions among patients who received
Vosevi in the POLARIS studies were headache, diarrhea and
nausea.
Sofosbuvir as a single agent was granted marketing authorization
in the European Union on January 16, 2014, under the trade name
Sovaldi®, for use in combination with other agents for the
treatment of adults with chronic HCV infection. The single tablet
regimen, Harvoni, received marketing authorization in the European
Union on November 18, 2014. The single tablet regimen of sofosbuvir
(400mg) and velpatasvir (100mg) received marketing authorization in
the European Union on July 8, 2016, under the trade name Epclusa®
for the treatment of adults with chronic HCV infection.
Vosevi was approved by the U.S. Food and Drug Administration on
July 18, 2017 for the re-treatment of adults with genotype 1-6
chronic HCV infection.
Important Safety Information for
Vosevi
Contraindications include hypersensitivity to the active
substances or to any of the excipients. Co-administration with
strong P-glycoprotein (P-gp) and/or strong cytochrome P450 (CYP)
inducers (e.g. rifampicin, rifabutin, St. John’s wort [Hypericum
perforatum], carbamazepine, phenobarbital and phenytoin) are
contraindicated. Co-administration with strong OATP1B inhibitors
(e.g. ciclosporin), rosuvastatin, dabigatran etexilate and
ethinylestradiol-containing medicinal products is also
contraindicated.
Patients co-infected with hepatitis C and hepatitis B are
at risk of hepatitis B virus reactivation and should therefore be
monitored and managed according to current clinical guidelines.
Caution and frequent renal monitoring is recommended for
co-administration with certain HIV antiretroviral treatments (e.g.
tenofovir disoproxil fumarate- and efavirenz-containing regimens).
Safety has not been established in patients with severe renal
impairment (glomerular filtration rate <30ml/min).
Monitoring of digoxin and amiodarone is recommended when used
with sofosbuvir/velpatasvir/voxilaprevir.
The “interaction with other medicinal products and other forms
of interaction” section of the Vosevi EU Summary of Product
Characteristics (SmPC) should be consulted before starting therapy
with sofosbuvir/velpatasvir/voxilaprevir.
Sofosbuvir/velpatasvir/voxilaprevir should not be administered
concomitantly with other medicinal products containing
sofosbuvir.
In clinical studies, headache, diarrhoea and nausea were the
most commonly reported adverse drug reactions.
Important Safety Information for
Harvoni
Contraindications include hypersensitivity to the active
substances or to any of the excipients. Co-administration with
rosuvastatin or St. John’s wort (Hypericum perforatum) is
contraindicated. Co-administration with certain P-glycoprotein
(P-gp) inducers (e.g. rifampicin, carbamazepine and phenytoin) is
not recommended. For patients on statins dose reduction should be
considered and careful monitoring for statin adverse events
(myopathy and rhabdomyolysis) should be undertaken.
Patients co-infected with hepatitis C and hepatitis B are
at risk of hepatitis B virus reactivation and should therefore be
monitored and managed according to current clinical guidelines.
Caution and frequent renal monitoring is recommended for
co-administration with certain HIV antiretroviral regimens. Safety
has not been established in patients with severe renal
impairment.
Monitoring of digoxin and dabigatran is recommended when used
with ledipasvir/sofosbuvir.
Ledipasvir/sofosbuvir should not be administered concomitantly
with other medicinal products containing sofosbuvir.
In clinical studies headache, fatigue and nausea were more
common in patients treated with ledipasvir/sofosbuvir compared to
placebo.
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 worldwide. Gilead
has operations in more than 30 countries worldwide, with
headquarters in Foster City, California.
ForwardLooking
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 physicians may not see the benefits of
prescribing Vosevi for the treatment of adults with chronic HCV
infection or Harvoni for the treatment of adolescents with chronic
HCV infection. 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 March 31, 2017, 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.
Full European Summary of Product
Characteristics for Vosevi, Sovaldi, Harvoni and Epclusa are
available from the EMA website at www.ema.europa.eu.
Vosevi, Sovaldi, Harvoni and Epclusa are
trademarks or registered trademarks of Gilead Sciences, Inc. or its
related companies.
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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