Gilead Receives European Marketing Authorization for Eviplera®, a New Complete Once-Daily, Single-Tablet Regimen for HIV-1 I...
November 28 2011 - 1:00PM
Business Wire
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the
European Commission has granted marketing authorization for
Eviplera® (emtricitabine/rilpivirine/tenofovir disoproxil),
a complete once-daily single-tablet regimen for the treatment of
HIV-1 infection in antiretroviral treatment-naïve adults with a
viral load less than or equal to 100,000 HIV-1 RNA copies/mL.
Today’s authorization allows for the commercialization of Eviplera
in all 27 countries of the European Union (EU).
“As people with HIV are living and remaining on treatment
longer, the availability of new simplified therapeutic options has
become even more critical,” said Dr. Mark Nelson, Service Director
for the HIV Directorate, Chelsea and Westminster Hospital, London,
United Kingdom. “Eviplera has the potential to be an important new
treatment option for patients starting HIV therapy because it
streamlines an effective HIV treatment regimen into a single daily
tablet.”
Eviplera combines Gilead’s Truvada®, a fixed-dose
combination of the two nucleoside reverse transcriptase inhibitors
emtricitabine 200 mg and tenofovir disoproxil 245 mg, and Tibotec
Pharmaceuticals’ rilpivirine 25 mg, marketed by Janssen-Cilag
International N.V. as Edurant®.
“Gilead continues to lead the development of single-tablet
regimens because we and our partners recognize the ongoing need to
simplify HIV therapy,” said John C. Martin, PhD, Chairman and Chief
Executive Officer, Gilead Sciences. “With Eviplera, we are pleased
to expand the therapeutic options for European patients, and are
now working with national authorities to ensure the regimen is made
available across the EU as quickly as possible.”
Eviplera is the second single-tablet HIV regimen to be
authorized in the EU. The first, Atripla® (efavirenz 600
mg/emtricitabine 200 mg/tenofovir disoproxil 245 mg), became
available in 2007 and is also marketed by Gilead, in partnership
with Bristol-Myers Squibb and Merck & Co.
The authorization of Eviplera was supported by 48-week data from
two Phase 3 double-blind, active controlled, randomized studies
(ECHO and THRIVE) conducted by Tibotec that evaluated the safety
and efficacy of rilpivirine compared to efavirenz in
treatment-naïve HIV-infected adults. Both studies included a
background regimen of two nucleosides/nucleotides, which for the
majority of patients was Truvada. A bioequivalence study, conducted
by Gilead, demonstrated that the co-formulated single-tablet
regimen achieved the same levels of medication in the blood as
emtricitabine plus rilpivirine plus tenofovir disoproxil fumarate
administered separately. The single-tablet regimen received
regulatory authorization from the U.S. Food and Drug Administration
under the trade name Complera®
(emtricitabine/rilpivirine/tenofovir disoproxil fumarate) in August
2011.
Gilead first entered into a license and collaboration agreement
with Tibotec for the development and commercialization of this
single-tablet regimen in July 2009. Under the terms of the
agreement, Gilead will assume the lead role in the manufacturing,
registration, distribution and commercialization of the product in
the United States, Canada, Brazil, the European Union, Australia
and New Zealand. Tibotec will be responsible for the
commercialization of rilpivirine as a single agent and will hold
rights to co-detail the single-tablet regimen in these
territories.
The companies also have finalized an agreement for the
development and commercialization of this single-tablet regimen for
the rest of world, including resource-limited settings. Gilead will
be responsible for the registration, distribution and
commercialization of the single-tablet regimen in certain European
countries, Latin America and the Caribbean. Tibotec will be
responsible for all countries outside of the Gilead territories,
the most significant of which include Asia Pacific, including
Japan, the Middle East, Eastern Europe and all of Africa.
EU IMPORTANT PRODUCT INFORMATION ABOUT EVIPLERA
- Lactic acidosis, usually associated
with hepatic steatosis, has been reported with the use of
nucleoside analogues, including emtricitabine and tenofovir
disoproxil fumarate. Lactic acidosis has a high mortality and
patients at increased risk should be followed closely.
- Eviplera should not be taken with any
of the following as significant decreases in the plasma
concentrations of rilpivirine may occur which may cause loss of
therapeutic effect of Eviplera:-the anticonvulsants carbamazepine,
oxcarbazepine, phenobarbital, phenytoin-the antimycobacterials
rifabutin, rifampicin, rifapentine-proton pump inhibitors, such as
omeprazole, esomeprazole, lansoprazole, pantoprazole,
rabeprazole-the systemic glucocorticoid dexamethasone, except as a
single dose treatment-St John’s wort (Hypericum perforatum).
- In the pooled analysis from the two
Phase 3 clinical studies (ECHO and THRIVE), patients treated with
the Eviplera combination with a baseline viral load > 100,000
HIV-1 RNA copies/mL had a greater risk of virologic failure than
patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL.
Patients with a baseline viral load > 100,000 HIV-1 RNA
copies/mL who experienced virologic failure exhibited a higher rate
of treatment emergent resistance to the non-nucleoside reverse
transcriptase inhibitor (NNRTI) class. More patients who failed
virologically on rilpivirine than who failed virologically on
efavirenz developed lamivudine/emtricitabine-associated resistance.
Eviplera has not been evaluated in patients with previous virologic
failure to any other antiretroviral therapy. As with other
antiretrovirals, resistance testing should guide the use of
Eviplera.
- As a fixed combination, Eviplera should
not be co-administered with other medicines containing
emtricitabine, rilpivirine hydrochloride or tenofovir disoproxil
fumarate. Due to similarities between emtricitabine and lamivudine,
Eviplera should not be administered with medicines containing
lamivudine. Eviplera should not be co-administered with adefovir
dipivoxil.
- Rilpivirine at supratherapeutic doses
(75 mg and 300 mg once daily) has been associated with prolongation
of the QTc interval of the electrocardiogram (ECG). Eviplera should
be used with caution when co-administered with medicinal products
with a known risk of Torsade de Pointes.
- Rare events of renal failure, renal
impairment, elevated creatinine, hypophosphataemia and proximal
tubulopathy (including Fanconi syndrome) have been reported with
the use of tenofovir disoproxil fumarate.
- It is recommended that creatinine
clearance is calculated in all patients prior to initiating therapy
with Eviplera and renal function (creatinine clearance and serum
phosphate) is also monitored every four weeks during the first year
and then every three months. In patients at risk for renal
impairment, more frequent monitoring should be considered.
- Use of Eviplera should be avoided with
concurrent or recent use of nephrotoxic medications. If concomitant
use of Eviplera and nephrotoxic agents is unavoidable, renal
function must be monitored weekly.
- Eviplera is not recommended for
patients with moderate or severe renal impairment (creatinine
clearance < 50 mL/min) as the appropriate dose interval
adjustment of emtricitabine and tenofovir disoproxil fumarate
cannot be achieved with the combination tablet.
- Bone abnormalities (infrequently
leading to fractures) may be associated with proximal renal
tubulopathy and appropriate consultation should be obtained if
suspected.
- Eviplera has not been studied in
patients with severe hepatic impairment (CPT Score C) and is
therefore not recommended in these patients. If Eviplera is
discontinued in patients co infected with HIV and hepatitis B virus
(HBV), these patients should be closely monitored for evidence of
exacerbation of hepatitis. In patients with advanced liver disease
or cirrhosis, treatment discontinuation is not recommended since
post treatment exacerbation of hepatitis may lead to hepatic
decompensation.
- Immune reconstitution syndrome has been
reported in patients treated with combination therapy, including
the components of Eviplera.
- Redistribution and/or accumulation of
body fat have been observed in patients taking anti-HIV medicines.
The cause and long-term health effect of these conditions are
unknown.
This does not include all data contained in the Eviplera Summary
of Product Characteristics (SmPC). Please see the complete SmPC for
further details.
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.
Headquartered in Foster City, California, Gilead has operations in
North America, Europe and Asia Pacific.
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 physicians may not see advantages of
Eviplera over other therapies and may therefore be reluctant to
prescribe the product. 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, 2011, 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.
EU Summaries of Product Characteristics for
Eviplera, Truvada and Atripla are available at
www.ema.europa.eu.
U.S. full prescribing information for Truvada
is available at www.Truvada.com.U.S. full prescribing information
for Atripla is available at www.Atripla.com.U.S. full prescribing
information for Complera is available at www.Complera.com.
Eviplera, Truvada and Complera are registered
trademarks of Gilead Sciences, Inc. or its related companies.
Atripla is a registered trademark of
Bristol-Myers Squibb & Gilead Sciences, LLC.Edurant is a
registered trademark of Tibotec, Inc.
For more information on Gilead Sciences, please
visit the company’s website at www.gilead.com or call Gilead Public
Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
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