TIDMGSK
RNS Number : 8298V
GlaxoSmithKline PLC
05 December 2019
Issued: 5 December 2019, London UK - LSE Announcement
PRESS RELEASE
ViiV Healthcare submits New Drug Application to the FDA for
fostemsavir, an investigational, first-in-class attachment
inhibitor for the treatment of HIV in adults with few treatment
options available
London, 5 December 2019 - ViiV Healthcare, the global specialist
HIV company majority owned by GSK, with Pfizer Inc. and Shionogi
Limited as shareholders, today completed submission of a New Drug
Application (NDA) to the US Food and Drug Administration (FDA)
seeking approval of fostemsavir, an investigational, first-in-class
attachment inhibitor for the treatment of HIV-1 infection.
Fostemsavir is being developed for use in combination with other
antiretroviral agents in heavily treatment-experienced adults with
multidrug-resistant HIV-1 infection who are unable to form a
suppressive regimen due to resistance, intolerance or safety
considerations.
Antiretroviral medicines that can effectively suppress HIV have
been instrumental in decreasing disease progression, HIV
transmission, and AIDS-related deaths, but because of HIV's ability
to constantly change, some individuals can develop viral resistance
to antiretroviral medicines, causing their treatment regimens to
fail. Challenges with tolerability, safety, and drug-to-drug
interactions may further decrease the number of acceptable
antiretroviral therapies available to design effective treatment
regimens. There remains an unmet need for these individuals who are
considered heavily treatment-experienced and who are unable to
successfully suppress their HIV.
Deborah Waterhouse, CEO of ViiV Healthcare, said: "Fostemsavir
may provide an important treatment option for the group of people
living with HIV who, for a variety of reasons, are not able to
suppress their virus with other medicines and could be left with
few or no treatments available to them. In keeping with our mission
of leaving no person with HIV behind, we have overcome many
barriers to bring this important new medicine to people living with
HIV, including investing in what is a very complex manufacturing
process. We look forward to working with the FDA to make
fostemsavir available to the people in the US who need it."
This submission is supported by the data from the pivotal phase
III BRIGHTE study in heavily treatment-experienced people living
with multidrug-resistant HIV. The 96-week results from the BRIGHTE
study were most recently presented in July at the 10(th)
International AIDS Society Conference on HIV Science (IAS 2019) in
Mexico City.
Kimberly Smith, M.D., Head of Research & Development at ViiV
Healthcare, said: "We've made incredible strides in our
understanding and treatment of HIV over the past 30 years. However,
the complexities of the virus mean that unsuccessful treatment and
antiviral resistance are still major concerns for certain people
living with HIV. Through our perseverance in research and
development, these individuals may soon have an entirely new way to
target and treat HIV with fostemsavir, aiding them in their efforts
to achieve viral suppression."
Fostemsavir has been granted FDA Fast Track and Breakthrough
Therapy Designations. These programmes are intended to facilitate
and expedite the development and review of new drugs to address
unmet medical need in the treatment of a serious or
life-threatening condition. Eligibility for Breakthrough Therapy
Designation requires that preliminary clinical evidence indicate
that the drug may demonstrate substantial improvement on clinically
significant endpoint(s) over available therapies.
ViiV Healthcare plans to submit regulatory applications for
fostemsavir to the European Medicines Agency and other global
agencies in the coming months.
About BRIGHTE
The efficacy of fostemsavir in heavily treatment-experienced
adults with HIV-1 infection is based on 96-week data from the phase
III, partially-randomised, international, double-blind,
placebo-controlled BRIGHTE study (NCT02362503).
The BRIGHTE trial was conducted in 371 heavily
treatment-experienced adults living with HIV-1 infection with
multidrug resistance. All trial participants were required to have
a viral load >=400 copies/mL and <=2 classes of
antiretroviral medications remaining at baseline due to resistance,
intolerability, contraindication, or other safety concerns. Trial
participants were enrolled in either a randomised or nonrandomised
cohort defined as follows:
-- Within the randomised cohort (n = 272), participants had 1,
but no more than 2, fully active and available antiretroviral
agent(s) at screening which could be combined as part of an
efficacious background regimen. Randomised participants received
either blinded fostemsavir 600 mg twice daily (n = 203) or placebo
(n = 69) in addition to their current failing regimen for 8 days of
functional monotherapy. Beyond Day 8, randomised participants
received open-label fostemsavir 600 mg twice daily plus an
investigator-selected optimised background therapy.
-- Within the nonrandomised cohort (n = 99), participants had no
fully active and approved antiretroviral agent(s) available at
screening. Nonrandomised participants were treated with open-label
fostemsavir 600 mg twice daily plus OBT from Day 1 onward. The use
of an investigational drug(s) as a component of the optimised
background therapy was permitted in the nonrandomised cohort.
The primary endpoint analysis, based on the adjusted mean
decline in HIV-1 RNA from Day 1 at Day 8 in the randomised cohort,
demonstrated superiority of fostemsavir to placebo (0.79 vs. 0.17
log10 copies/mL decline, respectively; P<0.0001,
Intent-to-Treat-Exposed [ITT-E] population). In the randomised
cohort, HIV-1 RNA <40 copies/mL was achieved in 53%, 54%, and
60% of subjects at Weeks 24, 48, and 96, respectively (ITT-E,
Snapshot algorithm). Mean changes in CD4+ cell count from baseline
continued to increase over time (i.e., 90 cells/mm3 at Week 24, 139
cells/mm3 at Week 48, and 205 cells/mm3 at Week 96). The most
common adverse reactions (incidence >=5%, all grades) were
nausea and diarrhoea. The proportion of participants who
discontinued treatment with fostemsavir due to an adverse event was
7% at Week 96 (randomised: 5% and nonrandomised: 12%).
About fostemsavir
Fostemsavir, an investigational prodrug of temsavir, is a
first-in-class HIV-1 attachment inhibitor that works by binding
directly to the glycoprotein 120 (gp120) subunit on the surface of
the virus. By binding to this location on the virus, fostemsavir
blocks HIV from attaching to host immune system CD4+ T-cells and
other immune cells, thereby preventing HIV from infecting those
cells and multiplying. Because of this unique mechanism of action,
there is no demonstrated resistance to other classes of
antiretrovirals, which may help patients who have become resistant
to most other medicines. Fostemsavir is not yet approved by
regulatory authorities anywhere in the world and is being developed
by ViiV Healthcare for the treatment of HIV-1-infected heavily
treatment-experienced patients in combination with other
antiretroviral agents.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established
in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:
PFE) dedicated to delivering advances in treatment and care for
people living with HIV and for people who are at risk of becoming
infected with HIV. Shionogi joined in October 2012. The company's
aim is to take a deeper and broader interest in HIV/AIDS than any
company has done before and take a new approach to deliver
effective and innovative medicines for HIV treatment and
prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio,
pipeline and commitment, please visit www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company with a special
purpose: to help people do more, feel better, live longer. For
further information please visit www.gsk.com.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item 3.D
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2018.
ViiV Healthcare Media
enquiries: Melinda Stubbee +1 919 491 0831
Audrey Abernathy +1 919 605 4521
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
Kristen Neese
+1 804 217 8147
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
Danielle Smith +44 (0) 20 8047 0932
James Dodwell +44 (0) 20 8047 2406
Jeff McLaughlin +1 215 751 7002
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END
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