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 December 2021
Commission
File Number 001-15170
GlaxoSmithKline 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 . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
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by check mark if the registrant is submitting the Form 6-K in paper
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Issued: 20 December 2021, London UK - LSE announcement
ViiV Healthcare announces US FDA
approval of Apretude (cabotegravir extended-release injectable
suspension), the first and only long-acting injectable option for
HIV prevention
●
Given as
few as six times per year and demonstrated superior efficacy to a
daily oral PrEP option (FTC/TDF tablets) in reducing the risk of
HIV acquisition
●
Approved in
the US for use in adults and adolescents weighing at least 35 kg
who are at risk of sexually acquiring HIV, including men who have
sex with men as well as women and transgender women who have sex
with men
London, 20 December 2021 -
ViiV Healthcare, the global specialist HIV company majority
owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer)
and Shionogi Limited (Shionogi) as shareholders, today announced
that the US Food and Drug Administration (FDA)
approved Apretude, the first and only long-acting injectable
pre-exposure prophylaxis (PrEP) option to reduce the risk of
sexually acquired HIV-1. The long-acting injectable was approved
for use in adults and adolescents weighing at least 35 kg who are
at risk of sexually acquiring HIV and who have a negative HIV-1
test prior to initiation. The medicine was studied in men who have
sex with men, as well as women and transgender women who have sex
with men, who were at increased risk of sexually acquiring
HIV.
Cabotegravir long-acting for PrEP is provided as an injection given
as few as 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. Vocabria (cabotegravir oral tablets) may be
administered for approximately one month before initiating the
first injection to assess the tolerability of the
medicine.
Deborah Waterhouse, CEO, ViiV Healthcare, said: "People who are vulnerable to acquiring HIV,
especially those in Black and Latinx communities who are
disproportionately impacted in the US, may want options beyond
daily oral pills. That's why ViiV Healthcare is proud
that Apretude was studied in one of the most diverse and
comprehensive HIV prevention trial programs to date, which also
included some of the largest numbers of transgender women and Black
men who have sex with men ever enrolled in an HIV prevention trial.
With Apretude, people can reduce the risk of acquiring HIV with
as few as six injections a year. Today's approval is the
latest example of ViiV Healthcare's commitment to developing
long-acting medicines that offer consumers a different
choice."
US FDA approval is based on the results from two international
phase IIb/III multicenter, randomised, double-blind,
active-controlled trials, HPTN 083 and HPTN 084, which evaluated
the safety and efficacy of cabotegravir long-acting for PrEP in
HIV-negative men who have sex with men, transgender women, and
cisgender women, who were at increased risk of sexually acquiring
HIV. In these trials, which included more than 7,700 participants
across 13 countries combined, the blinded, randomised portions of
both trials were stopped early by an independent Data Safety
Monitoring Board after cabotegravir long-acting for PrEP was shown
to be superior to daily oral emtricitabine/tenofovir disoproxil
fumarate (TDF/FTC) tablets in preventing the acquisition of HIV in
study participants. Clinical trial participants who received
cabotegravir long-acting for PrEP experienced a 69% lower incidence
of HIV compared to FTC/TDF tablets in HPTN 083 and a 90% lower
incidence of HIV compared to FTC/TDF tablets in HPTN
084.
The most common adverse reactions (all grades) observed in at least
1% of clinical trial participants receiving cabotegravir
long-acting for PrEP were injection site reactions, diarrhoea,
headache, pyrexia, fatigue, sleep disorders, nausea, dizziness,
flatulence, abdominal pain, vomiting, myalgia, rash, decreased
appetite, somnolence, back pain, and upper respiratory tract
infection. Adverse events led to discontinuation in 6% of
participants in HPTN 083 and 1% of participants in HPTN
084.
In HPTN 083, participants in the US were inclusive of the
Black/African American and Latinx communities of men and
transgender women who have sex with men, who are disproportionately
affected by the HIV epidemic and comprise the greatest percentage
of new HIV diagnoses. In HPTN 084, all participants were cisgender
women from sub-Saharan Africa. Women in this region bear a
disproportionate burden of the HIV epidemic and may be twice as
likely to acquire HIV as their male counterparts.
Richard Elion, MD, Director of Research at Washington Health
Institute, said: "We have the
tools to end the HIV epidemic through the implementation of
effective antiretroviral treatment and HIV prevention. PrEP has
played a vital role in protecting people from acquiring HIV. With
the availability of cabotegravir long-acting for PrEP as an
injection every two months to prevent HIV, people now have an
important new option besides daily medication. This long-acting
medication offers more options for prevention, and now providers
and patients will be empowered by choices and the ability to choose
the approach that is optimal for each
individual."
HIV continues to be a global public health crisis, with an
estimated 38 million people living with HIV worldwide and 1.7
million new cases annually. PrEP represents an effective tool to
reduce new cases of HIV, which in addition to successful HIV
antiretroviral treatment, will help efforts to end the HIV
epidemic. However, fewer than 25% of the people who could benefit
from PrEP in the US are currently taking it. Despite the wide
availability of daily oral PrEP, it can be limited by inconsistent
adherence as well as structural and cultural barriers that lead to
underutilisation in key populations.
Gabriel Maldonado, MBA, Executive Director and CEO, TruEvolution,
said: "Many people who are
vulnerable to HIV have complex lives that can make taking a daily
pill to prevent HIV a burden. This can include stigma, fears about
accidental disclosure of their medicine, as well as general
complications from daily living. Together, these issues may
contribute to low rates of PrEP usage and the expansion of the HIV
epidemic. Our community has been in dire need of additional HIV
prevention options that may address their evolving needs, and
cabotegravir long-acting for PrEP represents an exciting new option
to help them reduce their risk of acquiring
HIV."
ViiV Healthcare will begin shipping Apretude to wholesalers and specialty distributors in
the US in early 2022. ViiV Healthcare has initiated submissions to
other regulatory authorities. Apretude has not been approved or licensed anywhere
outside of the US for use in HIV prevention.
About Apretude (cabotegravir extended-release
injectable suspension)
Apretude is the first and
only long-acting injectable pre-exposure prophylaxis (PrEP) option
proven superior to daily oral FTC/TDF in reducing HIV acquisition.
It is indicated for HIV PrEP in adults and adolescents at risk of
sexually acquiring HIV, weighing at least 35 kg, who have a
negative HIV-1 test prior to initiation. Apretude is administered as a single 600 mg (3-ml)
intramuscular (IM) injection of cabotegravir in the buttocks by a
health care provider every two months after two initiation
injections administered one month apart and an optional oral
lead-in to assess tolerability.
Apretude 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.
About HPTN 083 (NCT02720094)
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 TDF/FTC. The trial design included an
oral lead-in phase to assess tolerability to cabotegravir before
administering the 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
had evidence of behaviour that would put them at high risk for
sexually acquiring HIV-1. The trial was conducted at research
centres in Argentina, Brazil, Peru, the United States, South
Africa, Thailand and Vietnam.1
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)
The HPTN 084 trial is a phase IIb/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 intramuscular 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.2
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.
Indication and Important Safety
Information for Apretude (cabotegravir 200 mg/mL extended-release
injectable suspension)
Apretude is an HIV-1 integrase strand transfer inhibitor
(INSTI) indicated in at-risk adults and
adolescents weighing at least 35 kg for pre-exposure
prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1
infection. Individuals must have a negative HIV-1 test prior to
initiating Apretude (with or without an oral lead-in with
oral cabotegravir) for
HIV-1 PrEP. Apretude is administered as a
single 600-mg (3-mL) intramuscular (IM) injection of cabotegravir
in the muscle of the buttock by a health care
professional once every 2 months.
WARNING: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE FOR HIV-1
PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED HIV-1
INFECTION
See full prescribing information for complete boxed
warning.
Individuals must be tested for HIV-1 infection prior to initiating
Apretude or oral cabotegravir, and with each subsequent injection
of Apretude, using a test approved or cleared by the FDA for the
diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1
variants have been identified with use of Apretude for HIV-1 PrEP
by individuals with undiagnosed HIV-1 infection. Do not initiate
Apretude for HIV-1 PrEP unless negative infection status is
confirmed. Individuals who become infected with HIV-1 while
receiving Apretude for PrEP must transition to a complete HIV-1
treatment regimen.
CONTRAINDICATIONS
●
Unknown or positive HIV-1
status.
●
Previous
hypersensitivity reaction to
cabotegravir.
●
Coadministration with drugs where significant
decrease in cabotegravir plasma concentrations may
occur.
WARNINGS AND PRECAUTIONS
●
Use APRETUDE for HIV-1 PrEP to
reduce the risk of HIV-1 infection as part of comprehensive
management to reduce the risk of HIV-1
acquisition.
●
Potential
risk of developing resistance to Apretude if an
individual acquires HIV-1 either before or while
taking Apretude or following discontinuation
of Apretude. Reassess risk of HIV-1 acquisition and
test before each injection to confirm HIV-1 negative
status.
●
Residual
concentrations of cabotegravir may remain in the systemic
circulation of individuals up to 12 months or
longer.
●
Hypersensitivity reactions have been reported in
association with other integrase inhibitors.
Discontinue Apretude immediately if signs or symptoms of
hypersensitivity reactions develop.
●
Hepatotoxicity has been reported in patients
receiving cabotegravir. Clinical and laboratory monitoring should
be considered. Discontinue Apretude if hepatotoxicity is
suspected.
●
Depressive
disorders have been reported with Apretude. Prompt evaluation
is recommended for depressive symptoms.
ADVERSE REACTIONS
The most common adverse reactions (all grades) observed in at least
1% of subjects receiving Apretude were injection site
reactions, diarrhea, headache, pyrexia, fatigue, sleep
disorders, nausea, dizziness, flatulence, abdominal pain,
vomiting, myalgia, rash, decreased appetite, somnolence, back pain,
and upper respiratory tract infection.
To report SUSPECTED ADVERSE REACTIONS,
contact ViiV Healthcare at 1-877-844-8872 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
●
Refer to
the full prescribing information for important drug interactions
with Apretude.
●
Drugs that
induce uridine diphosphate glucuronosyltransferase (UGT1A1) may
significantly decrease plasma concentrations of
cabotegravir.
USE IN SPECIFIC POPULATIONS
●
Lactation:
Assess the benefit-risk of using Apretude to the infant
while breastfeeding due to the potential for adverse reactions and
residual concentrations in the systemic circulation for up to 12
months or longer after
discontinuation.
●
Pediatrics: Not recommended in individuals
weighing less than 35 kg.
Please see full Prescribing
Information.
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 GlaxoSmithKline (LSE/NYSE: 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 shareholders 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 www.viivhealthcare.com.
About GSK
GSK is a science-led global healthcare company. For further
information please visit https://www.gsk.com/en-gb/about-us/.
ViiV Healthcare
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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 in the Company's
Annual Report on Form 20-F for 2020, GSK's Q3 2021 Results and any
impacts of the COVID-19 pandemic.
Registered in England & Wales:
GSK
PLC ViiV
Healthcare Limited
No. 3888792 No.
06876960
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
__________________________
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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GlaxoSmithKline plc
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(Registrant)
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Date: December
21, 2021
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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 GlaxoSmithKline plc
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