– Gilead’s First TAF-based Regimen to Receive CHMP Positive
Opinion –
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Committee
for Medicinal Products for Human Use (CHMP), the scientific committee of
the European Medicines Agency (EMA), has adopted a positive opinion on
the company’s Marketing Authorization Application (MAA) for the
investigational, once-daily single tablet regimen Genvoya®
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
alafenamide (TAF) 10 mg) for the treatment of HIV-1 infection. The data
submitted in the MAA support the use of the regimen among adult and
adolescent treatment-naïve individuals, virologically suppressed adults
who switch regimens and adults with mild-to-moderate renal impairment.
The CHMP’s recommendation will now be reviewed by the European
Commission, which has the authority to approve medicines for use in the
28 countries of the European Union. If authorized, Genvoya would be
Gilead’s first single tablet regimen to contain TAF.
TAF is a novel investigational nucleotide reverse transcriptase
inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose
less than one-tenth that of Gilead’s Viread® (tenofovir
disoproxil fumarate, TDF), as well as improvement in surrogate
laboratory markers of renal and bone safety as compared to TDF in
clinical trials in combination with other antiretroviral agents.
The MAA for Genvoya is supported by 48-week data from two pivotal Phase
3 studies (Studies 104 and 111) in which the regimen met its primary
objective of non-inferiority compared to Gilead’s Stribild® (elvitegravir
150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil
fumarate 300 mg) among treatment-naïve adult patients. In the studies,
Genvoya demonstrated improvement in surrogate laboratory markers of
renal and bone safety as compared to Stribild. The MAA is also supported
by data from additional Phase 3 studies evaluating the TAF-based regimen
among adolescents, virologically suppressed adult patients who switched
to Genvoya and adult patients with mild-to-moderate renal impairment.
In addition to Genvoya, two other TAF-based regimens are currently under
evaluation by the EMA. The first is an investigational, fixed-dose
combination of emtricitabine 200 mg and tenofovir alafenamide 25 or
10 mg (F/TAF) for use in combination with other antiretroviral agents.
The second is an investigational, once-daily single tablet regimen that
combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and
rilpivirine 25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are
from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland
UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
TAF and all TAF-based regimens are investigational products and their
safety and efficacy have not been established in the European Union.
About Gilead
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 MAA for Genvoya, F/TAF and/or R/F/TAF may not be approved by
the EMA, and marketing approvals, if granted, may have significant
limitations on their 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 June 30, 2015, 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.
The European SmPCs for Stribild and Viread are available from the EMA
website at www.ema.europa.eu.
Genvoya, Stribild and Viread are 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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