TIDMGSK
RNS Number : 9373G
GlaxoSmithKline PLC
01 June 2017
Issued: Thursday 01 June 2017, London UK - LSE announcement
ViiV Healthcare submits regulatory applications for the first
HIV maintenance regimen comprising only two medicines
- EU and US submissions for single tablet combining dolutegravir and rilpivirine
- Priority review voucher submitted in US with anticipated target action date of 6 months
London, UK 01 June 2017 - GSK and ViiV Healthcare, the global
specialist HIV company majority-owned by GSK, with Pfizer Inc. and
Shionogi Limited as shareholders, today announced regulatory
submissions to the European Medicines Agency (EMA) and US Food and
Drug Administration (FDA) for a single-tablet, two-drug regimen of
dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant,
Janssen Sciences Ireland UC) for the maintenance treatment of HIV-1
infection.
The submissions are based on the SWORD studies that included
more than one thousand patients who previously achieved viral
suppression on a three- or four-drug (integrase inhibitor,
non-nucleoside reverse transcriptase inhibitor, or protease
inhibitor-based) antiretroviral regimen. The results of these
studies were presented at the 2017 Conference on Retroviruses and
Opportunistic Infections (CROI) in February.
A recently acquired priority review voucher was submitted to the
FDA along with the dolutegravir and rilpivirine 2-drug regimen New
Drug Application (NDA). Under the Prescription Drug User Fee Act,
the anticipated target action date is six months after receipt of
the application by the FDA. The $130 million cost of the voucher
will be reported as an R&D expense in GSK's Q2 2017 Adjusted
results.
Use of dolutegravir and rilpivirine as a two-drug regimen for
HIV-1 maintenance therapy is investigational and not approved
anywhere in the world.
Deborah Waterhouse, CEO ViiV Healthcare said, "As people living
with HIV plan their lives, there is a need for new options to best
manage their lifelong treatment. At ViiV Healthcare, we are not
only developing potential new medicines to treat and prevent HIV
infection, we are challenging the traditional HIV treatment
paradigm to develop new treatment regimens. We look forward to
working with regulatory authorities to bring this new single
tablet, two-drug regimen to appropriate people living with
HIV."
John C Pottage, Jr, MD, Chief Scientific and Medical Officer,
ViiV Healthcare, commented,
"Traditionally, we have used a regimen of three or more drugs to
maintain HIV viral suppression, but to best serve people living
with HIV we must always question the status quo. We believed that
dolutegravir would have the right profile to be a core agent in a
two-drug regimen. Data from the SWORD studies supported our
hypothesis that a two-drug regimen of dolutegravir and rilpivirine
could maintain viral suppression and these regulatory submissions
mark what may be a step change in HIV treatment. We are grateful to
the study participants and clinicians who have contributed so much
to making these submissions possible."
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences, one of the
Janssen Pharmaceutical Companies of Johnson & Johnson,
announced a partnership to investigate the potential of combining
dolutegravir and rilpivirine in a single tablet in order to expand
the treatment options available to people living with HIV.
About the SWORD phase III programme for dolutegravir (Tivicay)
and rilpivirine (Edurant)
The phase III programme evaluates the efficacy, safety, and
tolerability of switching to dolutegravir plus rilpivirine from
current integrase inhibitor-, non-nucleoside reverse transcriptase
inhibitor-, or boosted protease inhibitor-based antiretroviral
regimen in HIV-1-infected adults who are virologically suppressed
with a three or four-drug regimen. SWORD-1 (NCT02429791) and
SWORD-2 (NCT02422797) are replicate 148-week, randomised,
open-label, non-inferiority studies to assess the antiviral
activity and safety of a two-drug, daily oral regimen of
dolutegravir plus rilpivirine compared with current antiretroviral
therapy. In the clinical trials, dolutegravir and rilpivirine are
provided as individual tablets.
The primary endpoint is the proportion of patients with plasma
HIV-1 RNA <50 copies per millilitre (c/mL) at Week 48. Key
secondary endpoints include evaluation of the development of viral
resistance, measurements of safety and tolerability, and changes in
renal, bone and cardiovascular biomarkers. The studies also include
exploratory measures to assess change in health-related quality of
life, willingness to switch and adherence to treatment
regimens.
For more information on the trials please visit:
www.clinicaltrials.gov
Tivicay is a registered trademark of the ViiV Healthcare group
of companies
Edurant is a registered trademark of Janssen Sciences Ireland
UC
TIVICAY (dolutegravir) tablets
Important Safety Information for TIVICAY(R) (dolutegravir) 10-,
25-, and 50-mg tablets, for oral use
The following Important Safety Information (ISI) is based on the
Highlights section of the US Prescribing Information for TIVICAY
and local variations apply. Please consult the full Prescribing
Information for all the labeled safety information for TIVICAY or
please refer to applicable local labelling.
FDA INDICATIONS AND USAGE
TIVICAY is a human immunodeficiency virus type 1 (HIV-1)
integrase strand transfer inhibitor (INSTI) indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and pediatric patients weighing at least
30 kg.
Limitations of Use:
-- Use of TIVICAY in integrase strand transfer inhibitor
(INSTI)-experienced patients should be guided by the number and
type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg
twice daily is reduced in patients with an INSTI-resistance Q148
substitution plus 2 or more additional INSTI-resistance
substitutions including T66A, L74I/M, E138A/K/T, G140S/A/C,
Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R.
CONTRAINDICATIONS
-- Previous hypersensitivity reaction to dolutegravir.
-- Coadministration with dofetilide.
WARNINGS AND PRECAUTIONS
-- Hypersensitivity reactions characterized by rash,
constitutional findings, and sometimes organ dysfunction, including
liver injury, have been reported. Discontinue TIVICAY and other
suspect agents immediately if signs or symptoms of hypersensitivity
reactions develop, as a delay in stopping treatment may result in a
life-threatening reaction.
-- Patients with underlying hepatitis B or C may be at increased
risk for worsening or development of transaminase elevations with
use of TIVICAY. Appropriate laboratory testing prior to initiating
therapy and monitoring for hepatotoxicity during therapy with
TIVICAY is recommended in patients with underlying hepatic disease
such as hepatitis B or C.
-- Redistribution/accumulation of body fat and immune
reconstitution syndrome have been reported in patients treated with
combination antiretroviral therapy.
ADVERSE REACTIONS
The most common adverse reactions of moderate to severe
intensity and incidence at least 2% (in those receiving TIVICAY in
any one adult trial) are insomnia, fatigue, and headache.
DRUG INTERACTIONS
-- Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir.
-- TIVICAY should be taken 2 hours before or 6 hours after
taking cation-containing antacids or laxatives, sucralfate, oral
supplements containing iron or calcium, or buffered medications.
Alternatively, TIVICAY and supplements containing calcium or iron
can be taken together with food.
USE IN SPECIFIC POPULATIONS
-- Pregnancy: TIVICAY should be used during pregnancy only if
the potential benefit justifies the potential risk.
-- Lactation: Breastfeeding is not recommended.
Please visit the following link for the full U.S. prescribing
and patient information:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF#page=1
EDURANT(R) Consumer Indication and Important Safety Information
(ISI)
About EDURANT(R)
-- EDURANT(R) (rilpivirine) is a prescription HIV medicine that
is used with other antiretroviral medicines to treat Human
Immunodeficiency Virus-1 (HIV-1) in patients:
- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called "viral load")
that is no more than 100,000 copies/mL. Your healthcare
professional will measure your viral load
-- EDURANT(R) should be taken in combination with other HIV
medicines. Your healthcare professional will work with you to find
the right combination of HIV medicines
-- It is important that you remain under the care of your
healthcare professional during treatment with EDURANT(R)
-- EDURANT(R) is not recommended for patients less than 12 years of age
EDURANT(R) does not cure HIV infection or AIDS. You should
remain on your HIV medications without stopping to ensure that you
control your HIV infection and decrease the risk of HIV-related
illnesses. Ask your healthcare professional about how to prevent
passing HIV to other people.
Please read Important Safety Information below, and talk to your
healthcare professional to learn if EDURANT(R) is right for
you.
Important Safety Information
Can EDURANT(R) be taken with other medicines?
EDURANT(R) may affect the way other medicines work and other
medicines may affect how EDURANT(R) works and may cause serious
side effects. If you take certain medicines with EDURANT(R), the
amount of EDURANT(R) in your body may be too low and it may not
work to help control your HIV infection, and the HIV virus in your
body may become resistant to EDURANT(R) or other HIV medicines that
are like it. To help get the right amount of medicine in your body,
you should always take EDURANT(R) with a meal. A protein drink
alone does not replace a meal.
Do not take EDURANT(R) if:
-- Your HIV infection has been previously treated with HIV medicines
-- You are taking any of the following medicines:
- Anti-seizure medicines: carbamazepine (Carbatrol(R),
Equetro(R), Tegretol(R), Tegretol-XR(R), Teril(R), Epitol(R)),
oxcarbazepine (Trileptal(R)), phenobarbital (Luminal(R)), phenytoin
(Dilantin(R), Dilantin-125(R), Phenytek(R))
- Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater(R),
Rifamate(R), Rimactane(R), Rifadin(R)), rifapentine
(Priftin(R))
- Proton pump inhibitor (PPI) medicine for certain stomach or
intestinal problems: esomeprazole (Nexium(R), Vimovo(R)),
lansoprazole (Prevacid(R)), omeprazole (Prilosec(R), Zegerid(R)),
pantoprazole sodium (Protonix(R)), rabeprazole (Aciphex(R))
- More than 1 dose of the steroid medicine dexamethasone or
dexamethasone sodium phosphate
- St. John's wort (Hypericum perforatum)
Especially tell your doctor if you take:
-- Rifabutin (Mycobutin(R)), a medicine to treat some bacterial
infections). Talk to your doctor or pharmacist about the right
amount of EDURANT(R) you should take if you also take rifabutin
-- Medicines used to treat HIV
-- An antacid medicine that contains aluminum, magnesium
hydroxide, or calcium carbonate. Take antacids at least 2 hours
before or at least 4 hours after you take EDURANT(R)
-- Medicines to block acid in your stomach, including cimetidine
(Tagamet(R)), famotidine (Pepcid(R)), nizatidine (Axid(R)), or
ranitidine hydrochloride (Zantac(R)). Take these medicines at least
12 hours before or at least 4 hours after you take EDURANT(R)
-- Any of these medicines (if taken by mouth or injection):
clarithromycin (Biaxin(R)), erythromycin (E-Mycin(R), Eryc(R),
Ery-Tab(R), PCE(R), Pediazole(R), Ilosone(R)), fluconazole
(Diflucan(R)), itraconazole (Sporanox(R)), ketoconazole
(Nizoral(R)), methadone (Dolophine(R)), posaconazole (Noxafil(R)),
telithromycin (Ketek(R)), voriconazole (Vfend(R))
This is not a complete list of medicines. Before starting
EDURANT(R),
be sure to tell your healthcare professional about all the
medicines you are taking or plan to take, including prescription
and nonprescription medicines, vitamins, and herbal
supplements.
Before taking EDURANT(R), also tell your health-care
professional if you have had or currently have liver problems
(including hepatitis B or C), have ever had a mental health
problem, are pregnant or planning to become pregnant, or
breastfeeding. It is not known if EDURANT(R) will harm your unborn
baby.
You and your health-care professional will need to decide if
taking EDURANT(R)
is right for you.
- Do not breastfeed if you are taking EDURANT(R). You should not
breastfeed if you have HIV because of the chance of passing HIV to
your baby
What are the possible side effects of EDURANT(R)? EDURANT(R) can
cause serious side effects including:
-- Severe skin rash and allergic reactions. Call your doctor
right away if you get a rash. Stop taking EDURANT(R) and seek
medical help right away if you get a rash with any of the following
symptoms: severe allergic reaction causing swelling of the face,
eyes, lips, mouth, tongue, or throat (which may lead to difficulty
swallowing or breathing); mouth sores or blisters on your body;
inflamed eye (conjunctivitis); fever; dark urine; or pain on the
right side of the stomach area (abdominal pain)
-- Depression or mood changes. Tell your doctor 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 yourself
-- Liver problems. 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. Liver problems were also reported during
treatment in some people without a history of liver disease. Your
health-care professional may need to do tests to check liver
function before and during treatment
-- Changes in body shape or body fat have been seen in some
patients taking HIV medicines. The exact cause and long-term health
effects of these conditions are not known
-- Changes in your immune system (immune reconstitution syndrome).
Your immune system may get stronger and begin to fight
infections. Tell your health-care professional right away if you
start having any new symptoms of infection
Other 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
professional right away. Do not stop taking EDURANT(R) or any other
medications without first talking to your healthcare
professional.
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.
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.
GSK - one of the world's leading research-based pharmaceutical
and healthcare companies - is committed to improving the quality of
human life by enabling people to do more, feel better and live
longer. For further information please visit www.gsk.com.
GSK enquiries:
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8047 5502
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8047 5502
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1048 DC)
Sarah Spencer +1 215 751 (Philadelphia)
3335
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
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Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
ViiV Healthcare Sébastien +44 (0) 20 (London)
Media enquiries Desprez 8380 6275
Patricia O'Connor +44 (0) 208 (London)
047 5982
Marc Meachem +1 919 483 (North
8756 Carolina)
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 2016.
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