European CHMP Adopts Positive Opinion for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine...
25 September 2015 - 9:33PM
Business Wire
– 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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version on businesswire.com: http://www.businesswire.com/news/home/20150925005258/en/
Gilead Sciences, Inc.Investors:Sung Lee, +1 650-524-7792Media
(U.S.):Ryan McKeel, +1 650-377-3548Media (EU):Kristine Kelly, +44
(0)78 1086 8956
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