a8334m
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 September 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 . . . . . . . .
Issued: 19 September 2023, London UK
European Commission authorises ViiV
Healthcare's Apretude (cabotegravir long-acting and tablets) for
HIV prevention
●
Given as few as six times per
year, cabotegravir has demonstrated superior efficacy to a daily
oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV
acquisition in clinical trials.[1],[2],[3],[4]
●
With
approximately 100,000 people newly diagnosed with HIV each year in
Europe,[5] expanding
HIV prevention options is crucial in reducing HIV
transmission.
GSK plc (LSE/NYSE: GSK) announced
that ViiV Healthcare, the global specialist HIV company majority
owned by GSK, with Pfizer and Shionogi as shareholders, today
announced that the European Commission has
authorised Apretude (cabotegravir
long-acting (LA) injectable and tablets) for HIV prevention.
Cabotegravir is indicated in combination with safer sex practices
for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually
acquired HIV-1 infection in high-risk adults and adolescents (at
least 12 years of age), weighing at least 35
kg.
Cabotegravir LA injectable and tablets for PrEP is the first and
only HIV prevention option approved in the European Union (EU) that
reduces the number of doses needed for effective HIV prevention
from 365 daily pills to as few as six injections per year.
Cabotegravir LA injectable and tablets for PrEP has demonstrated
superior efficacy to daily oral emtricitabine/tenofovir disoproxil
fumarate (FTC/TDF) in reducing the risk of HIV acquisition in
clinical trials, giving people in the EU more options for
PrEP.1,2,3,4
Deborah Waterhouse, CEO at ViiV Healthcare,
said: "This
authorisation marks a pivotal milestone for people across the EU
who could benefit from an innovative, long-acting HIV prevention
option that may better suit their personal preferences. Long-acting
PrEP, alongside other HIV prevention strategies, plays an important
role in helping to address some of the challenges that people may
have with oral PrEP options".
This approval is supported by data from two international phase
IIb/III multicentre, randomised, double-blind, active controlled
studies, HPTN 083 and HPTN 084, which evaluated the safety and
efficacy of cabotegravir LA for PrEP in HIV-negative men who have
sex with men (MSM), transgender women and cisgender women who were
at increased risk of sexually acquired HIV. The studies
demonstrated that cabotegravir LA for PrEP was superior to daily
oral FTC/TDF tablets, with clinical trial participants given
cabotegravir LA for PrEP experiencing a 69% lower rate of HIV
acquisition compared to FTC/TDF tablets in HPTN 083 (12 vs 39;
annual incidence: 0.37% vs 1.22%; HR 0.31 [CI: 0.16, 0.58]), and a
90% lower rate of HIV acquisition compared to FTC/TDF tablets in
HPTN 084 (3 vs 36; annual incidence: 0.15% vs 1.85%; HR 0.10 [CI:
0.04, 0.27]).1,2,3,4
Cabotegravir LA for PrEP is approved for use in the US, Australia,
South Africa, as well as other countries
as Apretude.
Submission to other regulatory agencies is
on-going.
About cabotegravir extended-release injectable
suspension
Cabotegravir long-acting for HIV prevention is the first and only
long-acting injectable PrEP option proven superior to daily oral
FTC/TDF in reducing HIV acquisition.
Cabotegravir long-acting for PrEP is an integrase strand transfer
inhibitor (INSTI). INSTIs, like cabotegravir extended-release
injectable suspension, 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
disease.
Cabotegravir long-acting for PrEP is provided as an injection
administered six times per year and is initiated with a single 600
mg (3-ml) injection given one month apart for two consecutive
months. After the second initiation injection, the recommended
continuation injection dose is a single 600 mg (3-ml) injection
given every two months. Cabotegravir oral tablets may be
administered for approximately one month before initiating the
first injection to assess the tolerability of the
medicine.
About HPTN 083 (NCT02720094)1,3
The HPTN 083 trial is a phase IIb/III double blind non-inferiority
trial designed to evaluate the safety and efficacy of long-acting
injectable cabotegravir for HIV prevention administered every eight
weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). The
trial included the prespecified ability to test for superiority of
long-acting cabotegravir over FTC/TDF.
The trial design included an oral lead-in phase to assess
tolerability to cabotegravir before administering the intramuscular
(IM) injection. Each participant was to receive a maximum of three
years of blinded trial medication. The trial opened to enrolment in
November 2016. HPTN 083 was conducted in 4,566 HIV-negative men who
have sex with men and transgender women who have sex with men, who
are at increased risk of HIV acquisition. The trial is being
conducted at research centres in Argentina, Brazil, Peru, the
United States, South Africa, Thailand, and Vietnam.
Long-acting cabotegravir was found to be superior to daily oral
FTC/TDF in preventing HIV acquisition in the trial population. The
most common adverse reactions (all grades) observed in at least 1%
of subjects receiving long-acting cabotegravir were injection site
reactions, diarrhoea, headache, pyrexia, fatigue, sleep disorders,
nausea, dizziness, flatulence, and abdominal pain.
For further information on HPTN 083 please see
https://clinicaltrials.gov/ct2/show/NCT02720094.
About HPTN 084 (NCT03164564)2,4
The HPTN 084 trial is a phase III double blind superiority trial
designed to evaluate the safety and efficacy of the long-acting
injectable cabotegravir for HIV prevention administered every eight
weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in
3,224 cisgender women who are at increased risk of HIV acquisition.
The trial design included an oral lead-in phase to assess
tolerability to cabotegravir before administering the IM injection.
HPTN 084 opened to enrolment in November 2017 and is being
conducted at research centres in Botswana, Kenya, Malawi, South
Africa, Eswatini, Uganda, and Zimbabwe.
Long-acting cabotegravir was found to be superior to daily oral
FTC/TDF in preventing HIV acquisition in the trial population. The
most common adverse reactions (all grades) observed in at least 1%
of subjects receiving long-acting cabotegravir were injection site
reactions, diarrhoea, headache, fatigue, sleep disorders, nausea,
dizziness, abdominal pain, vomiting, myalgia, and
rash.
For further information please see
https://clinicaltrials.gov/ct2/show/NCT03164564.
The Apretude EMA Reference Information, including a full
list of adverse events and the complete important safety
information in the EU, will shortly be available on the European
Medicines Agency website.
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 could benefit from HIV prevention options.
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.
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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 and any impacts of the COVID-19
pandemic.
Registered in England & Wales:
No.
3888792
Registered Office:
980
Great West Road
Brentford,
Middlesex
TW8
9GS
References
[1] Landovitz RJ, Donnell D, Clement
ME, et al. Cabotegravir for HIV Prevention
in Cisgender Men and Transgender Women. The New England Journal of
Medicine 2021;385:595-608. DOI:
10.1056/NEJMoa2101016
[2] Delaney-Moretlwe S, Hughes J,
Bock P, et al. Cabotegravir for the prevention of HIV-1 in women:
results from HPTN 084, a phase 3, randomised clinical trial. The
Lancet 2022;399(10337):1779-1789. DOI:
10.1016/S0140-6736(22)00538-4
[3] Clinical Trials.gov - Safety and
Efficacy Study of Injectable Cabotegravir Compared to Daily Oral
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For
Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and
Transgender Women Who Have Sex With Men. Available
at
https://clinicaltrials.gov/ct2/show/NCT02720094. Last accessed
August 2023.
[4] Clinical Trials.gov - Evaluating
the Safety and Efficacy of Long-Acting Injectable Cabotegravir
Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in
HIV-Uninfected Women. Available at
https://clinicaltrials.gov/ct2/show/NCT03164564. Last accessed
August 2023.
[5] ECDC/World Health Organisation
(2021) HIV/AIDS surveillance in Europe. Available at
https://www.ecdc.europa.eu/sites/default/files/documents/2021-Annual_HIV_Report_0.pdf.
Last accessed March 2023. Last accessed August
2023.
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: September
19, 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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