TIDMGSK
RNS Number : 4039X
GlaxoSmithKline PLC
29 April 2019
Issued: 29 April 2019, London UK - LSE Announcement
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, 29 April 2019 - 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 rilpivirine.
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 months.
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 as EDURANT(R)).
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(R) (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 U.S. and E.U. as EDURANT(R) 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(R)
(Rilpivirine)
Note: this is taken from the US label and local variations
apply. Please refer to applicable local labelling.
About EDURANT(R) (Rilpivirine)
-- EDURANT(R) (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(R) is not recommended for patients less than 12 years
of age or who weigh less than 77 lbs (35 kg)
IMPORTANT SAFETY INFORMATION
Who should not take EDURANT(R)?
Do not take EDURANT(R) if you also take:
-- anti-seizure medicines:
o carbamazepine
o oxcarbazepine
o phenobarbital
o phenytoin
-- anti-tuberculosis (anti-TB) medicines:
o rifampin
o rifapentine
-- proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
o esomeprazole
o lansoprazole
o omeprazole
o pantoprazole sodium
o 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(R)?
Before taking EDURANT(R), 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(R) will harm your unborn baby. Tell your healthcare
provider if you become pregnant during treatment with
EDURANT(R).
-- are breastfeeding or plan to breastfeed. Do not breastfeed if you take EDURANT(R).
o You should not breastfeed if you have HIV-1 because of the
risk of passing HIV-1 to your baby.
o It is not known if EDURANT(R) passes into your breast milk.
Talk with your healthcare provider about the best way to feed your
baby during EDURANT(R) treatment.
Tell your healthcare provider about all the medicines you take,
including 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(R) with other medicines.
How should I take EDURANT(R)?
-- Take EDURANT(R) every day exactly as your healthcare provider tells you to.
-- Take EDURANT(R) 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(R) without
first talking with your healthcare provider. Stay under the care of
your healthcare provider during treatment with EDURANT(R).
-- Do not miss a dose of EDURANT(R).
-- If you take an H(2) -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 EDURANT(R).
-- 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(R).
-- If you miss a dose of EDURANT(R) within 12 hours of the time
you usually take it, take your dose of EDURANT(R) with a meal as
soon as possible. Then, take your next dose of EDURANT(R) at the
regularly scheduled time. If you miss a dose of EDURANT(R) by more
than 12 hours of the time you usually take it, wait and then take
the next dose of EDURANT(R) at the regularly scheduled time.
-- Do not take more than your prescribed dose to make up for a missed dose.
-- If you take too much EDURANT(R), call your healthcare
provider or go to the nearest hospital emergency room right
away.
What are the possible side effects of EDURANT(R)?
EDURANT(R) can cause serious side effects including:
-- Severe skin rash and allergic reactions. Skin rash is a
common side effect of EDURANT(R). 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 EDURANT(R) and get medical help right away:
o fever o trouble breathing or swallowing
o skin blisters o pain on the right side of
o mouth sores the stomach (abdominal) area
o redness or swelling of the o dark-colored urine "tea colored"
eyes (conjunctivitis)
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(R). Liver problems
have also happened during treatment with EDURANT(R) 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(R).
-- Depression or mood changes. Tell your healthcare provider
right away if you have any of the following symptoms:
o feeling sad or hopeless
o feeling anxious or restless
o have thoughts of hurting yourself (suicide) or have tried to
hurt yourself
-- 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 known.
-- 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(R) include 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(R) 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 www.fda.gov/medwatch, 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:
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/EDURANT-pi.pdf
For the EU Summary of Product Characteristics, please visit:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002264/WC500118874.pdf
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 Melinda Stubbee +1 919 491 0831 (US)
enquiries:
Audrey Abernathy +1 919 605 4521 (US)
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
(UK)
Kristen Neese +1 804 217 8147 (US)
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
(UK)
Danielle Smith +44 (0) 20 8047 0932
James Dodwell (UK)
+44 (0) 20 8047 2406
(UK)
Jeff McLaughlin +1 215 751 7002 (US)
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END
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