UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of October 2023
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . .
Form 40-F . . . . . . .
..
26 October 2023, London UK
ViiV Healthcare receives approval from
China's National Medical Products Administration (NMPA)
for Vocabria (cabotegravir) used in combination
with Rekambys (rilpivirine), the first and only complete
long-acting HIV-1 injectable treatment
●
The
marketing authorisation for rilpivirine long-acting injection was
received on the 18 October 2023
●
The
complete long-acting regimen enables people living with HIV in
China, who are virologically suppressed to reduce the treatment
dosing days from 365 to 12 or 6 per year after
initiation.
●
With an estimated 1.045 million
people living with HIV in China,[1] expanding treatment
options is critical to reduce the scale of the epidemic in the
country.
GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global
specialist HIV company majority owned by GSK, with Pfizer and
Shionogi as shareholders announced that the National Medical
Products Administration (NMPA) of China has approved ViiV
Healthcare's Vocabria (cabotegravir
injection) used in combination with the Janssen Pharmaceutical
Companies of Johnson & Johnson's Rekambys (rilpivirine
long-acting injection) for the treatment of HIV-1
infection. Prior
to the recent marketing authorisation for rilpivirine long-acting
injection, cabotegravir injection and tablets were approved in
China in July 2023.
Cabotegravir injection is indicated in combination with rilpivirine
long-acting injection for the treatment of human immunodeficiency
virus type-1 (HIV-1) infection in adults who are virologically
suppressed, on a stable antiretroviral (ARV) regimen without
present or past evidence of viral resistance to, and no prior
virological failure with, agents of the non-nucleoside reverse
transcriptase inhibitor (NNRTI) and integrase inhibitor (INI)
classes. Vocabria (cabotegravir) tablets are approved for use
in combination with rilpivirine tablets (trade
name Edurant) as an optional oral lead-in before initiating
injections or as oral therapy for those who will miss planned
injection doses.
By the end of October 2020, there were an estimated 1.045 million
people living with HIV in China.1 Advancements
in treatment mean many people living with HIV can now live long and
healthy lives, however, some may still struggle with daily oral HIV
medication. It may act as a constant reminder of HIV, be a cause of
fear that their HIV status will be accidently disclosed or create
challenges with adherence.
Deborah Waterhouse, CEO of ViiV Healthcare,
said: "At
ViiV Healthcare, we are proud to be able to offer innovative
solutions that meet the evolving needs of people living with HIV.
The approval of cabotegravir injection and rilpivirine long-acting
injection marks a step forward in helping to change the treatment
experience for some people living with HIV in China who may have
challenges with daily HIV therapies. We look forward to working
closely with our partners in China to make this treatment available
to those who could benefit from a long-acting regimen, part of our
commitment to ensuring no person living with HIV is left
behind."
This approval is based on data from three pivotal trials: the ATLAS
(Antiretroviral Therapy as Long-Acting Suppression) and FLAIR
(First Long-Acting Injectable Regimen) studies, and the phase IIIb
ATLAS-2M study, which collectively included more than 1,200
participants from 16 countries. ATLAS and FLAIR demonstrated the
efficacy and safety of cabotegravir and rilpivirine compared to
standard-of-care oral regimens, while ATLAS-2M showed that once
every two month dosing had comparable efficacy to once
monthly.[2],[3],[4] In
ATLAS, 92.5% of participants receiving long-acting therapy and
95.5% of those receiving oral therapy remained virally suppressed
at week 48 (adjusted difference: -0.3%; 95% confidence interval
[CI]: -6.7% to 0.7%), meeting the criterion for
non-inferiority.2 In
FLAIR, 93.6% of participants receiving long-acting therapy and
93.3% of participants receiving oral therapy remained virally
suppressed at week 48 (adjusted difference: 0.4%; 95% CI:
−3.7% to 4.5%), meeting the criterion for
non-inferiority.3 In
the pooled analysis of ATLAS and FLAIR most long-acting recipients
(83%) experienced injection site reactions, which decreased in
incidence over time. Injection site reactions led to the withdrawal
of 6 (1%) participants. The serious adverse event rate was 4% in
each arm.[5] In
ATLAS-2M, cabotegravir plus rilpivirine long-acting every eight
weeks was non-inferior to dosing every four weeks (adjusted
difference: 0.8%; 95% CI: -0.6% to 2.2%) after 48 weeks of
treatment. The safety profile was similar between dosing groups,
with 844 (81%) of 1,045 participants having adverse events
(excluding injection site reactions); no treatment-related deaths
occurred.4
ViiV Healthcare's mission is to leave no person living with HIV
behind. As the only pharmaceutical company solely focused on HIV
and AIDS, ViiV Healthcare is working to deliver a broad range of
treatments that meet the needs of a wide variety of people living
with HIV. The long-acting regimen approved on the 18 October 2023
was developed in collaboration between ViiV Healthcare and Janssen.
This builds on ViiV Healthcare's industry-leading portfolio which
is centred on delivering innovative medicines for the HIV
community.
About cabotegravir
Cabotegravir is an integrase strand transfer inhibitor (INSTI)
developed by ViiV Healthcare for the treatment of HIV-1 in
virologically suppressed adults. It is approved as a long-acting
formulation for use in combination with a rilpivirine long-acting
formulation in the US, the EU and in other countries.
INSTIs, like cabotegravir, inhibit HIV replication by preventing
the viral DNA from integrating into the genetic material of human
immune cells (T-cells). This step is essential in the HIV
replication cycle and is also responsible for establishing chronic
infection.
About rilpivirine and rilpivirine long-acting
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor
(NNRTI) that works by interfering with an enzyme called reverse
transcriptase, which in turn stops the virus from multiplying. It
is approved as Edurant, an oral formulation, for the treatment of
HIV-1 infection in combination with other antiretroviral agents in
antiretroviral treatment-naïve patients 12 years of age and
older and weighing at least 35kg with a viral load ≤100,000
HIV RNA copies/mL. It is also approved as Rekambys, a long-acting formulation that is indicated,
in combination with cabotegravir injection, 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 without present or past evidence of
viral resistance to, and no prior virological failure with, agents
of the NNRTI and INI class.
Administration and dosing of cabotegravir and
rilpivirine
Cabotegravir injection used in combination with rilpivirine
injection is a complete long-acting regimen dosed once monthly or
once every two months for the treatment of HIV-1 in adults who are
virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable
antiretroviral (ARV) regimen without present or past evidence of
viral resistance to, and no prior virological failure with, agents
of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and
integrase inhibitor (INI) classes. Cabotegravir and rilpivirine
should be administered intramuscularly (IM) at two separate,
gluteal injection sites by a healthcare professional at the same
appointment. Prior to the initiation of the injections,
cabotegravir and rilpivirine oral tablets can be taken as oral
lead-in for approximately one month (at least 28 days) to assess
tolerability to the medicines.
For once-monthly dosing, each person will receive a loading dose
that includes one 600 mg injection of cabotegravir and one 900 mg
injection of rilpivirine administered intramuscularly in the
gluteal site. Then, each month after that, each person will receive
one 400 mg injection of cabotegravir and one 600 mg injection of
rilpivirine.
For once every two months dosing, each person will receive a
loading dose that includes one 600 mg injection of cabotegravir and
one 900 mg injection of rilpivirine, which is repeated one month
later. Then, every two months after that, each person will receive
one 600 mg injection of cabotegravir and one 900 mg injection of
rilpivirine as a continuation dose.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in
November 2009 by GSK (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 acquiring HIV. Shionogi
became a ViiV shareholder in October 2012. The company's aims are
to take a deeper and broader interest in HIV and 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
viivhealthcare.com.
About GSK
GSK is a global biopharma company with a purpose to unite science,
technology, and talent to get ahead of disease together. Find out
more at gsk.com.
ViiV Healthcare enquiries
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Media:
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Nicola
Andre
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+44 (0)
7901 887073
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(London)
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Rachel
Jaikaran
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+44 (0)
7823 523755
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(London)
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Audrey
Abernathy
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+1 919
605 4521
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(North
Carolina)
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GSK enquiries
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Media:
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Tim
Foley
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+44 (0)
20 8047 5502
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(London)
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Sarah
Clements
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+44 (0)
20 8047 5502
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(London)
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Kathleen
Quinn
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+1 202
603 5003
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(Washington
DC)
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Lyndsay
Meyer
|
+1 202
302 4595
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(Washington
DC)
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Alison
Hunt
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+1 540 742 3391
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(Washington
DC)
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Investor
Relations:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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|
Mick
Readey
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+44 (0)
7990 339653
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(London)
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Josh
Williams
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+44 (0)
7385 415719
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(London)
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Camilla
Campbell
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+44 (0)
7803 050238
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(London)
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|
Steph
Mountifield
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+44 (0)
7796 707505
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
751 4855
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(Philadelphia)
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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
'Risk factors" in the company's Annual Report on Form 20-F for
2022, and Q2 Results for 2023.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1] Jun-Jie X, Meng-Jie H,
Yong-Jun J, et al. Prevention and control of HIV/AIDS in China:
lessons from the past three decades. Chinese Medical
Journal 2021;
134(23):2799-2809.
[2] Swindells S,
Andrade-Villanueva J-F, Richmond G, et al. Long-acting cabotegravir
and rilpivirine for maintenance of HIV-1
suppression. New England Journal of
Medicine 2020;
382:1112-1123.
[3] Orkin C, Arasteh K,
Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine
after oral induction for HIV-1 infection. New England Journal of
Medicine 2020;
382:1124-1135.
[4] Overton ET, Richmond
G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine
dosed every 2 months in adults with HIV-1 infection (ATLAS-2M),
48-week results: a randomised, multicentre, open-label, phase 3b,
non-inferiority study. The Lancet 2020;
396(10267):1994-2005.
[5] Rizzardini G, Overton
ET, Orkin C, et al. Long-Acting Injectable Cabotegravir +
Rilpivirine for HIV Maintenance Therapy: Week 48 Pooled Analysis of
Phase 3 ATLAS and FLAIR Trials. J Acquir Immune Defic
Syndr 2020;
1;85(4):498-506.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: October
26, 2023
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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