TIDMGSK
RNS Number : 7216O
GlaxoSmithKline PLC
21 May 2018
Issued: 21 may 2018, London UK - LSE Announcement
ViiV Healthcare receives EU marketing authorisation for Juluca
(dolutegravir/rilpivirine), the first 2-drug regimen, once-daily,
single-pill for the treatment of HIV
Juluca maintains viral suppression with two drugs in the
smallest single pill regimen
London, 21 May 2018 - ViiV Healthcare, the global specialist HIV
company, majority owned by GlaxoSmithKline, with Pfizer Inc. and
Shionogi Limited as shareholders, today announced that the European
Commission has granted marketing authorisation for Juluca
(dolutegravir 50mg/rilpivirine 25mg) for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in adults who are
virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable
antiretroviral regimen for at least six months with no history of
virological failure and no known or suspected resistance to any
non-nucleoside reverse transcriptase inhibitor or integrase
inhibitor.[1] Juluca is a 2-drug regimen of dolutegravir (ViiV
Healthcare), the most widely prescribed integrase inhibitor
worldwide,[2] and rilpivirine (Janssen Sciences Ireland UC, part of
the Janssen Pharmaceutical Companies of Johnson &
Johnson).1
Deborah Waterhouse, CEO ViiV Healthcare said, "The European
Commission Decision for Juluca is very positive news for people
living with HIV (PLHIV) across Europe, who will now have the
opportunity to maintain their viral suppression with a complete
treatment regimen composed of only two drugs within a single-pill.
Thanks to advances in treatment, many PLHIV who are on therapy are
living longer, with near-normal life expectancies. We listened to
their concerns about the potential long-term effects of being on
treatment for decades, and have developed a solution aligned with a
preference to streamline care by taking fewer antiretrovirals to
manage their HIV." [3]
This approval brings another treatment option to the estimated
810,000 PLHIV in Europe.[4] It follows the Positive Opinion from
the European Medicines Agency's (EMA) Committee for Human use of
Medicinal Products (CHMP) on 22 March 2018.[5] Juluca was approved
by the US Food and Drug Administration (FDA) in November 2017 and
Health Canada on 18 May 2018.[6](,[7])
John C Pottage, Jr, MD, Chief Scientific and Medical Officer,
ViiV Healthcare, commented, "We are delighted to be able to provide
dolutegravir with rilpivirine in a once-daily 2-drug regimen for
PLHIV. ViiV Healthcare is committed to delivering innovative
advances to meet the unmet needs of PLHIV and our robust clinical
research programme has the potential to revolutionalise how we care
for PLHIV for the long-term. With the advent of Juluca, we have
found a way to reduce the number of antiretrovirals whilst
maintaining the efficacy of the traditional 3-drug regimen. This is
already being recognised by the European AIDS Society (EACS 2017)
guidelines recommending a dolutegravir and rilpivirine regimen as a
switch option for virologically suppressed patients."[8]
Data from the SWORD studies, presented at the Conference for
Retroviruses and Opportunistic Infections (CROI) 2017 and later
published in The Lancet, showed that the dolutegravir and
rilpivirine regimen is non-inferior to traditional three and four
drug regimens in maintaining virologic suppression (HIV-1 RNA
<50 copies/mL) through 48 weeks in adults who are infected with
HIV-1, in both pooled and individual analyses of the SWORD-1 and
SWORD-2 studies (dolutegravir+rilpivirine 486/513 [95%] current
antiretroviral regimen 485/511 [95%], [adjusted difference -0.2%
(95% confidence interval:
-3.0%, 2.5%), pooled analysis]). The most commonly reported
(>5%) adverse events in the dolutegravir+rilpivirine arm were
nasopharyngitis, headache, diarrhoea and upper respiratory tract
infection. Participating adults had stable plasma HIV-1 RNA (viral
load <50 copies/mL) for 6 months or longer at screening, with no
resistance-associated major integrase inhibitor, protease
inhibitor, nucleoside and non-nucleoside reverse transcriptase
inhibitor mutations.[9]
- Ends -
Notes to editors
In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC,
one of the Janssen Pharmaceutical Companies of Johnson &
Johnson, announced a collaboration 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 HIV
HIV stands for the Human Immunodeficiency Virus. Unlike some
other viruses, the human body cannot get rid of HIV, so once
someone has HIV they have it for life. There is no cure for HIV,
but effective treatment can control the virus so that people with
HIV can enjoy healthy and productive lives.
HIV has largely become a chronic treatable disease with improved
access to antiretroviral treatment. This has led to a 22% drop in
global HIV mortality between 2009 and 2013,[10] but more can be
done for the estimated 36.7 million people living with HIV[11] of
which 160,000 were newly diagnosed in the Europe region alone in
2016.[12]
About Juluca (dolutegravir/rilpivirine)
Juluca was approved by the US Food and Drug Administration (FDA)
on 21 November 2017, as a complete regimen for the treatment of
HIV-1 infection in adults who are virologically suppressed (HIV-1
RNA less than 50 copies per mL) on a stable antiretroviral regimen
for at least 6 months with no history of treatment failure and no
known substitutions associated with resistance to the individual
components of dolutegravir/rilpivirine.6
Juluca is a 2-drug regimen, single pill that combines the
integrase inhibitor (INI) dolutegravir (50mg), with the
non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine
(25mg) taken once-daily as a complete HIV regimen for people living
with HIV who are virologically suppressed.1(,) 6
Two essential steps in the HIV life cycle include reverse
transcription - when the virus turns its RNA (ribonucleic acid)
copy into DNA (deoxyribonucleic acid) - and integration - the
moment when viral DNA becomes part of the host cell's DNA. These
processes require two enzymes called nucleoside reverse
transcriptase and integrase. NNRTIs and INIs interfere with the
action of these two enzymes to prevent the virus from replicating.
This decrease in replication can lead to less virus being available
to cause subsequent infection of uninfected cells.
ViiV Healthcare has also submitted regulatory marketing
applications in other countries worldwide.
About the SWORD phase III programme for dolutegravir (Tivicay)
and rilpivirine (Edurant)
The SWORD 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 (100-week data will be shared in Q3 2018 with the full
148-week data being shared in 2019). In the SWORD clinical trials,
dolutegravir and rilpivirine are provided as individual
tablets.[13](,[14])
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.13(,) 14
For more information on the trials please visit:
www.clinicaltrials.gov
Juluca and Tivicay are trademarks owned by the ViiV Healthcare
group of companies.
Edurant is a registered trademark of Janssen Sciences Ireland
UC.
Safety Information for Juluca in the European Union:1
Juluca (dolutegravir 50mg, rilpivirine 25mg) is contraindicated
in any patient with hypersensitivity to the active substances
dolutegravir or rilpivirine or to any of the excipients.
Juluca is contraindicated in patients taking:
- dofetilide
- the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- the antimycobacterials rifampicin, rifapentine
- proton pump inhibitors, such as omeprazole, esomeprazole,
lansoprazole, pantoprazole, rabeprazole
- the systemic glucocorticoid dexamethasone, except as a single dose treatment
- St John's wort (Hypericum perforatum)
Factors that decrease the exposure of the components of Juluca
should be avoided. Juluca should not be taken with any other
medicinal products containing dolutegravir or rilpivirine or
antiretroviral medicinal products used for the treatment of
HIV.
The safety and efficacy of Juluca has not yet been established
in patients <18 years and/or in women who are pregnant. Use of
Juluca in these patient populations is not recommended.
No dosage adjustment is required in patients with mild or
moderate renal impairment. In patients with severe or end stage
renal disease, the combination of Juluca with a strong CYP3A
inhibitor should only be used if the benefit outweighs the risk. No
data are available in subjects receiving dialysis although
differences in pharmacokinetics are not expected in this
population.
No dosage adjustment is required in patients with mild or
moderate hepatic impairment (Child-Pugh score A or B). Juluca
should be used with caution in patients with moderate hepatic
impairment. No data are available in patients with severe hepatic
impairment (Child-Pugh score C); therefore Juluca is not
recommended in these patients.
Hypersensitivity reactions have been reported with dolutegravir
and were characterised by rash, constitutional findings, and
sometimes, organ dysfunction, including severe liver reactions.
Juluca should be discontinued immediately if signs or symptoms of
hypersensitivity reactions develop (including, but not limited to,
severe rash or rash accompanied by raised liver enzymes, fever,
general malaise, fatigue, muscle or joint aches, blisters, oral
lesions, conjunctivitis, facial oedema, eosinophilia, angioedema).
Clinical status including liver aminotransferases and bilirubin
should be monitored. Delay in stopping treatment with Juluca after
the onset of hypersensitivity may result in a life-threatening
allergic reaction.
In HIV-infected patients with severe immune deficiency at the
time of institution of combination antiretroviral therapy (CART),
an inflammatory reaction to asymptomatic or residual opportunistic
pathogens may arise and cause serious clinical conditions, or
aggravation of symptoms. Typically, such reactions have been
observed within the first few weeks or months of initiation of
CART. Relevant examples are cytomegalovirus retinitis, generalised
and/or focal mycobacterial infections, and Pneumocystis jirovecii
pneumonia. Any inflammatory symptoms should be evaluated and
treatment instituted when necessary. Autoimmune disorders (such as
Graves' disease) have also been reported to occur in the setting of
immune reconstitution, however, the reported time to onset is more
variable and these events can occur many months after initiation of
treatment.
Monitoring of liver function is recommended in patients with
hepatitis B and/or C co-infection. No clinical data are available
in patients with hepatitis B co-infection. Physicians should refer
to current treatment guidelines for the management of HIV infection
in patients co-infected with hepatitis B virus. Limited data is
available in patients with hepatitis C co-infection. A higher
incidence of liver chemistry elevations (Grade 1) were observed in
patients treated with dolutegravir and rilpivirine co-infected with
hepatitis C compared to those who were not co-infected.
Patients should be advised that Juluca does not cure HIV
infection and that they may still develop opportunistic infections
and other complications of HIV infection. Therefore, patients
should remain under close clinical observation by physicians
experienced in the treatment of these associated HIV diseases.
Although the aetiology is considered to be multifactorial
(including corticosteroid use, biphosphonates, alcohol consumption,
severe immunosuppression, higher body mass index), cases of
osteonecrosis have been reported in patients with advanced
HIV-disease and/or long-term exposure to CART. Patients should be
advised to seek medical advice if they experience joint aches and
pain, joint stiffness or difficulty in movement.
At supra-therapeutic doses (75 and 300 mg once daily),
rilpivirine has been associated with prolongation of the QTc
interval of the electrocardiogram (ECG). Rilpivirine at the
recommended dose of 25 mg once daily is not associated with a
clinically relevant effect on QTc. Juluca should be used with
caution when co-administered with medicinal products with a known
risk of Torsade de Pointes.
Please refer to the full European Summary of Product
Characteristics for full prescribing information, including
contraindications, special warnings and precautions for use.1
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 - 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.
Cautionary statement regarding forward-looking statements
ViiV Healthcare Limited, the global specialist HIV company, is
majority owned by GlaxoSmithKline plc, with Pfizer Inc. and
Shionogi Limited. 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 2017.
ViiV Healthcare Media
enquiries: Patricia O'Connor +44 208 047 5982
Cara Vivarelli-O'Neill +1 919 483 0301
GSK Global Media enquiries: Simon Steel +44 (0) 20 8047 5502
Analyst/Investor enquiries: Sarah Elton-Farr +44 (0) 20 8047 5194
James Dodwell +44 (0) 20 8047 2406
Jeff McLaughlin +1 215 751 7002
References
[1] Juluca EU Summary of Product Characteristics
www.ema.europa.eu.
[2] Number of Patients on Dolutegravir, Worldwide, IMS data.
August 2017.
[3] ViiV Healthcare. Data on File - Positive Perspectives Survey
2017.
[4] Pharris A, et al. Estimating HIV incidence and number of
undiagnosed individuals living with HIV in the European
Union/European Economic Area, 2015. Euro Surveill. 2016 Dec 1;
21(48): 30417.
[5] CHMP meeting highlights 19-22 March.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002925.jsp&mid=WC0b01ac058004d5c1
Last accessed May 2018.
[6] Juluca (dolutegravir and rilpivirine) Prescribing
Information. U.S Approval 2017.
[7] Health Canada. Juluca certified product information
document. 18 May 2018.
[8] European AIDS Clinical Society Guidelines. Version 9.
October 2017.
[9] Llibre JM, et al. Efficacy, safety, and tolerability of
dolutegravir-rilpivirine for the maintenance of virological
suppression in adults with HIV-1: phase 3, randomised,
non-inferiority SWORD-1 and SWORD-2 studies. The Lancet. 2018 Mar
3;391(10123):839-849.
[10] World Health Organization. Global Update on the health
sector response to HIV, 2014. July 2014. Available at:
http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1
Last accessed May 2018.
[11] World Health Organization. HIV AIDS Factsheet 2017.
Available at: http://www.who.int/mediacentre/factsheets/fs360/en/
Last accessed May 2018.
[12] World Health Organization. Infographic - Newly diagnosed
HIV infections in the WHO European Region, 2016. Available at:
http://www.euro.who.int/en/health-topics/communicable-diseases/hivaids/data-and-statistics/infographic-newly-diagnosed-hiv-infections-in-the-who-european-region,
-2016 Last accessed May 2018.
[13] SWORD-1 - Regimen Switch to Dolutegravir + Rilpivirine From
Current Antiretroviral Regimen in Human Immunodeficiency Virus Type
1 Infected and Virologically Suppressed Adults (SWORD-1). Available
at:
https://clinicaltrials.gov/ct2/show/NCT02429791?term=dolutegravir+AND+sword&cond=HIV&rank=3
Last accessed May 2018.
[14] SWORD-2 - Regimen Switch to Dolutegravir + Rilpivirine From
Current Antiretroviral Regimen in Human Immunodeficiency Virus Type
1 Infected and Virologically Suppressed Adults (SWORD-2). Available
at:
https://clinicaltrials.gov/ct2/show/NCT02422797?term=dolutegravir+AND+sword&cond=HIV&rank=1
Last accessed May 2018.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
MSCEANSFASXPEEF
(END) Dow Jones Newswires
May 21, 2018 06:02 ET (10:02 GMT)
Gsk (LSE:GSK)
Gráfica de Acción Histórica
De Mar 2024 a Abr 2024
Gsk (LSE:GSK)
Gráfica de Acción Histórica
De Abr 2023 a Abr 2024