ViiV Healthcare Submits New Drug Application to US FDA for the First Monthly, Injectable, Two-Drug Regimen of Cabotegravir and Rilpivirine for Treatment of HIV

If approved, cabotegravir and rilpivirine would be the first-ever
long-acting, injectable treatment regimen for adults living with HIV

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by
GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today
submitted a New Drug Application (NDA) to the US Food and Drug
Administration (FDA) seeking approval for the investigational, monthly,
injectable, two-drug regimen of ViiV Healthcare’s cabotegravir and
Janssen’s rilpivirine to treat HIV-1 infection in adults whose viral
load is suppressed and who are not resistant to cabotegravir or

The submission is based on the global ATLAS (Antiretroviral Therapy as
Long-Acting Suppression) and FLAIR (First Long-Acting Injectable
Regimen) pivotal phase III studies that included more than 1,100
patients from 16 countries and demonstrated the combination of
cabotegravir and rilpivirine, injected monthly, was as effective as a
standard of care, daily, oral, three-drug regimen in maintaining viral
suppression throughout the 48-week study period. These results were
presented in March at the 2019 Conference on Retroviruses and
Opportunistic Infections.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “The
long-acting, once-monthly, injectable regimen of cabotegravir and
rilpivirine has the potential to give people living with HIV one month
between doses with similar safety and efficacy as today’s standard of
care – an oral three-drug regimen that has to be taken every day. ViiV
Healthcare is proud to be at the forefront of this innovation in HIV
treatment and we look forward to working with the FDA to provide people
living with HIV in the US this novel option.”

John C. Pottage, Jr., M.D., Chief Scientific and Medical Officer of
ViiV Healthcare, commented
: “Our focus on developing innovative new
HIV treatments, including long-acting injectable therapies, supports our
goal of giving people living with HIV more options for managing the
virus. The ATLAS and FLAIR data support the efficacy and safety of this
investigational two-drug regimen, and the fact that more than 85 percent
of study participants said they preferred it to their prior, daily oral
therapy suggests we are delivering a welcome option. If approved, people
receiving the monthly injectable regimen of cabotegravir and rilpivirine
will reduce the number of days they have to take treatment from 365 to
12 per year.”

ViiV Healthcare and Janssen plan to submit regulatory applications for
the two-drug regimen of cabotegravir and rilpivirine to the European
Medicines Agency, Health Canada and other global agencies in the coming

As part of the regulatory submission package to the FDA, ViiV Healthcare
submitted a second NDA for an oral tablet formulation of cabotegravir
that would be taken as an oral lead-in with an already-approved,
once-daily, oral tablet formulation of rilpivirine (marketed by Janssen

The ATLAS and FLAIR studies are part of ViiV Healthcare’s innovative
clinical trial programme for two-drug regimens.

Notes to editors: About ATLAS and FLAIR
ATLAS (NCT02951052)
is a phase III, open-label, active-controlled, multicentre,
parallel-group, non-inferiority study designed to assess the antiviral
activity and safety of a two-drug regimen of long-acting, injectable
cabotegravir and rilpivirine dosed every four weeks compared to
continuation of current oral anti-retroviral therapy (ART) of two
nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase
strand transfer inhibitor (INI), non-nucleoside reverse transcriptase
inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed
individuals. The primary endpoint for ATLAS is the proportion of
participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot
algorithm at Week 48 (Missing, Switch, or Discontinuation = Failure,
Intent-to-Treat Exposed [ITT-E] population). Subjects were required to
be virally suppressed for six months or greater, on first or second
regimen, with no prior failure.

FLAIR (NCT02938520)
is a phase III, randomised, open-label, multicentre, parallel-group,
non-inferiority study designed to assess the antiviral activity and
safety of a two-drug regimen of intramuscular, long-acting, injectable
cabotegravir and rilpivirine in virologically suppressed adults living
with HIV, following 20 weeks of induction therapy with Triumeq
(abacavir, dolutegravir, and lamivudine tablets). The primary endpoint
for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50
c/mL per the FDA Snapshot algorithm at Week 48 (Missing, Switch, or
Discontinuation = Failure, Intent-to-Treat Exposed [ITT-E] population).

About cabotegravir
Cabotegravir is an investigational
integrase inhibitor (INI) and is not approved by regulatory authorities
anywhere in the world. Cabotegravir is being developed by ViiV
Healthcare for the treatment and prevention of HIV. It is being
evaluated as a long-acting formulation for intramuscular injection and
also as a once-daily oral tablet for use as a lead-in, to establish the
tolerability of cabotegravir prior to long-acting injection.

About rilpivirine
EDURANT® (rilpivirine) is a
once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used
for the treatment of human immunodeficiency virus (HIV-1) infection in
combination with other antiretroviral agents in antiretroviral
treatment-naïve patients 12 years of age and older and weighing at least
35-kg with a viral load ≤ 100,000 HIV RNA copies/mL. Long-acting
injectable rilpivirine is not approved by regulatory authorities
anywhere in the world.

Rilpivirine was developed by Janssen Sciences Ireland UC, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson. Rilpivirine is
approved in the US and EU as EDURANT® as a 25mg tablet taken
once-a-day and is always taken with a meal. The most common side effects
of EDURANT include: depression, headache, trouble sleeping (insomnia)
and rash.

Important Safety Information (ISI) for EDURANT® (Rilpivirine)

Note: this is taken from the US label and local variations apply. Please
refer to applicable local labelling.

About EDURANT® (Rilpivirine)

  • EDURANT® (rilpivirine) is a prescription medicine that is
    used with other antiretroviral medicines to treat Human
    Immunodeficiency Virus-1 (HIV-1) in people 12 years of age and older
    and who weigh at least 77 lbs (35 kg):

    • Have never taken HIV medicines before, and
    • Have an amount of HIV in their blood (called “viral load”) that is
      no more than 100,000 copies/mL
  • EDURANT® is not recommended for patients less than 12 years
    of age or who weigh less than 77 lbs (35 kg)


Who should not take EDURANT®?

Do not take EDURANT® if you also take:

  • anti-seizure medicines:

    • carbamazepine
    • oxcarbazepine
    • phenobarbital
    • phenytoin
  • anti-tuberculosis (anti-TB) medicines:

    • rifampin
    • rifapentine
  • proton pump inhibitor (PPI) medicine for certain stomach or intestinal

    • esomeprazole
    • lansoprazole
    • omeprazole
    • pantoprazole sodium
    • rabeprazole
  • more than 1 dose of the steroid medicine dexamethasone or
    dexamethasone sodium phosphate
  • St. John’s wort (Hypericum perforatum)

What should I tell my healthcare provider before taking EDURANT®?
taking EDURANT
®, tell your healthcare provider
about all your medical conditions, including if you:

  • have or had liver problems, including hepatitis B or C virus infection
  • have kidney problems
  • have ever had a mental health problem
  • are pregnant or plan to become pregnant. It is not known if EDURANT®
    will harm your unborn baby. Tell your healthcare provider if you
    become pregnant during treatment with EDURANT®.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you
    take EDURANT

    • You should not breastfeed if you have HIV-1 because of the risk of
      passing HIV-1 to your baby.
    • It is not known if EDURANT® passes into your breast
      milk. Talk with your healthcare provider about the best way to
      feed your baby during EDURANT® treatment.

Tell your healthcare provider about all the medicines you take,
prescription and over-the-counter medicines, vitamins, and
herbal supplements.
Do not start taking a new medicine without
telling your healthcare provider.
Your healthcare provider can tell
you if it is safe to take EDURANT® with other medicines.

How should I take EDURANT®?

  • Take EDURANT® every day exactly as your healthcare provider
    tells you to.
  • Take EDURANT® 1 time each day with a meal. A
    protein drink alone does not replace a meal.
  • Do not change your dose or stop taking EDURANT® without
    first talking with your healthcare provider. Stay under the care of
    your healthcare provider during treatment with EDURANT®.
  • Do not miss a dose of EDURANT®.
  • If you take an H2-receptor antagonist (famotidine,
    cimetidine, nizatidine, or ranitidine), you should take these
    medicines at least 12 hours before or at least 4 hours after you take
  • If you take antacids, or other products that contain aluminum, calcium
    carbonate, or magnesium hydroxide, you should take these medicines at
    least 2 hours before or at least 4 hours after you take EDURANT®.
  • If you miss a dose of EDURANT® within 12 hours of the time
    you usually take it, take your dose of EDURANT® with a meal
    as soon as possible. Then, take your next dose of EDURANT®
    at the regularly scheduled time. If you miss a dose of EDURANT®
    by more than 12 hours of the time you usually take it, wait and then
    take the next dose of EDURANT® at the regularly scheduled
  • Do not take more than your prescribed dose to make up for a missed
  • If you take too much EDURANT®, call your healthcare
    provider or go to the nearest hospital emergency room right away.

What are the possible side effects of EDURANT®?
can cause serious side effects including:

  • Severe skin rash and allergic reactions. Skin rash is a common
    side effect of EDURANT®. Skin rash can be serious. Call
    your healthcare provider right away if you get a rash. In some cases,
    rash and allergic reaction may need to be treated in a hospital.

If you get a rash with any of the following symptoms, stop taking
® and get medical help right away:

o fever

o trouble breathing or swallowing

o skin blisters

o pain on the right side of the stomach
(abdominal) area

o mouth sores

o redness or swelling of the eyes (conjunctivitis)

o dark-colored urine “tea colored”

o swelling of the face, lips, mouth, tongue, or throat

  • Change in liver enzymes. People with a history of hepatitis B
    or C virus infection or who have certain liver function test changes
    may have an increased risk of developing new or worsening liver
    problems during treatment with EDURANT®. Liver problems
    have also happened during treatment with EDURANT® in people
    without a history of liver disease. Your healthcare provider may need
    to do tests to check your liver enzymes before and during treatment
    with EDURANT®.
  • Depression or mood changes. Tell your healthcare provider right
    away if you have any of the following symptoms:

    • feeling sad or hopeless
    • feeling anxious or restless
    • have thoughts of hurting yourself (suicide) or have tried to hurt
  • Changes in body fat can happen in people who take HIV medicine.
    These changes may include increased amount of fat in the upper back
    and neck (“buffalo hump”), breast, and around the middle of your body
    (trunk). Loss of fat from the legs, arms, and face may also happen.
    The exact cause and long-term health effects of these problems are not
  • Changes in your immune system (Immune Reconstitution Syndrome) can
    happen when you start taking HIV medicines. Your immune system may get
    stronger and begin to fight infections that have been hidden in your
    body for a long time. Tell your healthcare provider right away if you
    start having any new symptoms after starting your HIV-1 medicine.

The most common side effects of EDURANT®
depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects. If you experience these
or other symptoms, contact your healthcare provider right away. Do not
stop taking EDURANT® or any other medications without first
talking to your healthcare provider.

You are encouraged to report side effects of prescription drugs to
the FDA. Visit
or call 1-800-FDA-1088.
You may also report side effects to
Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).

Please see accompanying full Product Information for more details.

Full US prescribing information including is available at:

For the EU Summary of Product Characteristics, please visit:

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 as a shareholder 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 (US)

GSK Global Media enquiries:
Simon Steel, +44 (0) 20 8047 5502 (UK)
Neese, +1 804 217 8147 (US)

Analyst/Investor enquiries:
Sarah Elton-Farr, +44 (0) 20 8047 5194
Danielle Smith, +44 (0) 20 8047 0932 (UK)
James Dodwell,
+44 (0) 20 8047 2406 (UK)
Jeff McLaughlin, +1 215 751 7002 (US)

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