Submits Rilpivirine (TMC278) Single-tablet Regimen for FDA Approval
Gilead Sciences announced last week that it has
submitted a New Drug Application requesting U.S.
Food and Drug Administration (FDA) approval for
a once-daily single-tablet regimen containing the
next-generation non-nucleoside reverse transcriptase
inhibitor (NNRTI) rilpivirine
(TMC278) (developed by Tibotec) plus the nucleoside/nucleotide
reverse transcriptase inhibitors tenofovir
(the drugs in the Truvada
combination pill). As
recently reported, rilpivirine demonstrated
potent antiviral activity and good tolerability
in the Phase 3 ECHO and THRIVE trials.
is an edited excerpt from a Gilead press release describing
TMC278 and research supporting its approval. The full release,
including important safety information, is available online
Sciences Submits New Drug Application to U.S. FDA for Once-Daily
Single-Tablet Regimen of Truvada and TMC278 for HIV
Would Be Second Complete Single-Tablet Antiretroviral Regimen
City, Calif. -- November 23, 2010 -- 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 marketing approval of the single-tablet regimen
of Truvada (emtricitabine and tenofovir disoproxil fumarate)
and Tibotec Pharmaceuticals' investigational non-nucleoside
reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride)
for HIV-1 infection in adults. If approved, this would be
the second product that contains a complete HIV treatment
regimen in a single once-daily tablet.
antiretroviral therapy has dramatically advanced the field
of HIV medicine, but the need remains for new single-tablet
regimens that are effective, safe and well tolerated,"
said John C. Martin, PhD, Chairman and Chief Executive Officer,
Gilead Sciences. "Gilead is committed to helping advance
HIV treatment by pursuing both scientific research and innovative
partnerships that will deliver more options to the healthcare
community. We are pleased to work with Tibotec to bring this
potentially important new therapy to people living with HIV."
July 23, 2010, Tibotec submitted an NDA for U.S. marketing
approval of TMC278 for once-daily use with other antiretroviral
agents. That NDA is supported by 48-week data from two Phase
III double-blind, randomized studies (ECHO and THRIVE) that
evaluated the safety and efficacy of TMC278 in treatment-naive
HIV-1 infected adults, the majority of whom received TMC278
in combination with Truvada. The Gilead NDA for Truvada/TMC278
is supported by a bioequivalence study conducted by Gilead
demonstrating that the formulation of the single-tablet regimen
achieved the same levels of medication in the blood as the
component products dosed simultaneously as individual pills.
September 3, 2010, the European marketing applications for
TMC278 and for the Truvada/TMC278 single-tablet regimen were
filed simultaneously by Tibotec and Gilead, respectively.
entered into a license and collaboration agreement with Tibotec
for the development and commercialization of the single-tablet
regimen in July 2009. Subject to regulatory approval, Gilead
will assume the lead role in the manufacturing, registration,
distribution and commercialization of the single-tablet regimen
worldwide, excluding the developing world and Japan. Tibotec
will be responsible for the commercialization of TMC278 as
a stand-alone product and will hold rights to co-promote the
single-tablet regimen in these territories. The companies
are currently working on an agreement to make the combination
product available in the developing world.
is an investigational product and its safety and efficacy
have not yet been established.
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.
Gilead Sciences. Gilead Sciences Submits New Drug Application
to U.S. FDA for Once-Daily Single-Tablet Regimen of Truvada
and TMC278 for HIV. Press
release. November 23, 2010.