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 February 2022
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): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
ViiV Healthcare announces US FDA
approval of Cabenuva (cabotegravir, rilpivirine) for use every
two months, expanding the label of the first and only complete
long-acting HIV treatment
Cabenuva is now approved for administration as few as six times a
year for virologically suppressed adults living with HIV without
prior treatment failure or resistance to cabotegravir or
rilpivirine
London, 1 February 2022 -
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 Cabenuva (cabotegravir, rilpivirine) for
every-two-month dosing for the treatment of HIV-1 in virologically
suppressed adults (HIV-1 RNA less than 50 copies per millilitre
[c/ml]) on a stable regimen, with no history of treatment failure,
and with no known or suspected resistance to either cabotegravir or
rilpivirine.
Cabenuva is the first and
only complete long-acting HIV treatment regimen and was first
approved by the US FDA in January 2021 as a once-monthly treatment
for HIV-1 in virologically suppressed adults.1 It
contains ViiV Healthcare's cabotegravir extended-release injectable
suspension in a single-dose vial and rilpivirine extended-release
injectable suspension in a single-dose vial, a product of Janssen
Sciences Ireland Unlimited Company, one of the Janssen
Pharmaceutical Companies of Johnson & Johnson. The US FDA
approval allows Cabenuva to be dosed monthly or every two
months.
Lynn Baxter, Head of North America at ViiV Healthcare,
said: "ViiV Healthcare is
pleased to continue our leadership in researching and developing
long-acting innovative HIV treatment options that address the
evolving needs of the HIV community. Today's approval is a
remarkable achievement given where HIV treatment was just a decade
ago. We know some people living with HIV struggle with taking daily
oral pills, and Cabenuva may allow them to maintain viral suppression
while significantly reducing dosing to as few as six times a
year."
The US FDA approval of long-acting cabotegravir and rilpivirine for
use every two months is based on the global ATLAS-2M phase IIIb
trial results, which demonstrated that every-two-month dosing was
non-inferior to once-monthly dosing.2 Non-inferiority
was determined by comparing the proportion of participants with
plasma HIV-1 RNA ≥ 50 c/ml using the US FDA Snapshot
algorithm at Week 48 (Intent-to-Treat Exposed population), which
showed that the every-two-month arm (9/522 [1.7%]) and once-monthly
arm (5/523 [1.0%]) were similarly effective (adjusted difference:
0.8%, 95% confidence interval [CI]: -0.6%, 2.2%). The study also
found that rates of virologic suppression, a key secondary
endpoint, were similar for every-two-month dosing (492/522 [94.3%])
and once-monthly dosing (489/523 [93.5%]) (adjusted difference:
0.8%, 95% CI: -2.1%, 3.7%). The most common adverse reactions
(Grades 1 to 4) observed in ≥2% of participants receiving
long-acting cabotegravir and rilpivirine were injection site
reactions, pyrexia, fatigue, headache, musculoskeletal pain,
nausea, sleep disorders, dizziness, and rash. In ATLAS-2M, the type
and frequency of adverse reactions reported in participants
receiving long-acting cabotegravir and rilpivirine once monthly or
every two months for 48 weeks were similar. In the every-two-month
arm, rates of serious adverse events (SAEs: 27/522[5.2%]) and
withdrawals due to adverse events (AEs: 12/522 [2.3%]) were low and
similar to those experienced in the once-monthly arm (SAEs: 19/523
[3.6%], withdrawals due to AEs 13/523 [2.5%]).2
Turner Overton, MD, Professor, Department of Medicine at the
University of Alabama at Birmingham and ATLAS-2M Primary
Investigator, said: "Many people living with HIV face challenges
with daily therapies and are interested in alternative dosing
options. In clinical trials, approximately nine out of every ten
trial participants preferred long-acting cabotegravir and
rilpivirine dosed every two months compared to daily oral
cabotegravir and rilpivirine taken as the oral lead-in per trial
protocol. This preference data highlights the meaningful impact
long-acting regimens can have on the treatment experience for the
HIV community."
Patient preference data were collected from clinical trial
participants who received long-acting cabotegravir and rilpivirine.
In a pooled analysis of this intent-to-treat exposed population
with no prior experience with long-acting cabotegravir and
rilpivirine, 327 patients completed a single-item question at Week
48, and 92% (300/327) preferred every-two-month injections compared
with one per cent (4/327) who preferred oral cabotegravir and
rilpivirine that was taken as the required oral lead-in. These
results are descriptive in nature and should not be used
to infer clinical significance.3
About ATLAS-2M (NCT03299049)
The ATLAS-2M phase IIIb trial is an ongoing, randomised,
open-label, active-controlled, multicentre, parallel-group trial
designed to assess the non-inferior antiviral activity and safety
of long-acting cabotegravir and rilpivirine administered every
eight weeks (every two months, 3ml dose of each medicine) compared
to every four weeks (once monthly, 2ml dose of each medicine) over
a 48-week treatment period in 1,045 adults living with
HIV-1.2 Subjects
were required to be virologically suppressed for six months or
greater, on a first or second antiretroviral regimen, with no prior
virologic failure. The primary outcome measure for the
trial was the proportion of participants with HIV-1 RNA
≥ 50 c/ml at Week 48 using the US FDA Snapshot algorithm
(intent-to-treat exposed population). ATLAS-2M is part of ViiV
Healthcare's extensive and innovative clinical trial programme. It
is being conducted at research centres in Australia, Argentina,
Canada, France, Germany, Italy, Mexico, Russia, South Africa, South
Korea, Spain, Sweden and the United States.
For further information, please see https://clinicaltrials.gov/ct2/show/NCT03299049.
About Cabenuva (cabotegravir,
rilpivirine)
Cabenuva is indicated as a
complete regimen for the treatment of HIV-1 infection in adults to
replace the current antiretroviral regimen in those who are
virologically suppressed (HIV-1 RNA <50 c/ml) on a stable
antiretroviral regimen with no history of treatment failure and
with no known or suspected resistance to either cabotegravir or
rilpivirine.
The complete regimen combines the integrase strand transfer
inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with
rilpivirine, a non-nucleoside reverse transcriptase inhibitor
(NNRTI) developed by Janssen. Rilpivirine is approved in the US as
a 25mg tablet taken once a day to treat HIV-1 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 c/ml.
INSTIs 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. Rilpivirine
is an NNRTI that works by interfering with an enzyme called reverse
transcriptase, which stops the virus from multiplying.
Long-acting cabotegravir and rilpivirine are approved for use every
two months in Canada under the name Cabenuva and in the EU as Vocabria and Rekambys.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
Important Safety Information
for Cabenuva (cabotegravir; rilpivirine) extended-release
injectable suspensions
Cabenuva is indicated as a
complete regimen for the treatment of human immunodeficiency virus
type 1 (HIV-1) infection in adults to replace the current
antiretroviral regimen in those who are virologically suppressed
(HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral
regimen with no history of treatment failure and with no known or
suspected resistance to either cabotegravir or
rilpivirine.
CONTRAINDICATIONS
● Do not use Cabenuva in patients with previous hypersensitivity
reaction to cabotegravir or rilpivirine
● Do not use Cabenuva in patients receiving carbamazepine,
oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin,
rifapentine, systemic dexamethasone (>1 dose), and St John's
wort
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions:
● Hypersensitivity reactions, including cases of
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have
been reported during postmarketing experience with
rilpivirine-containing regimens. While some skin reactions were
accompanied by constitutional symptoms such as fever, other skin
reactions were associated with organ
dysfunctions, including elevations in hepatic
serum biochemistries
● Serious or severe hypersensitivity reactions have
been reported in association with other integrase inhibitors and
could occur with Cabenuva
● Discontinue Cabenuva immediately if signs or symptoms of
hypersensitivity reactions develop. Clinical status, including
liver transaminases, should be monitored and appropriate therapy
initiated. Prescribe the oral lead-in prior to administration
of Cabenuva to help identify patients who may be at risk
of a hypersensitivity reaction
Post-Injection Reactions:
● Serious post-injection reactions (reported in less
than 1% of subjects) were reported within minutes after the
injection of rilpivirine, including dyspnea, bronchospasm,
agitation, abdominal cramping, rash/urticaria, dizziness, flushing,
sweating, oral numbness, changes in blood pressure, and pain (e.g.,
back and chest). These events may have been associated with
inadvertent (partial) intravenous administration and began to
resolve within a few minutes after the
injection
● Carefully follow the Instructions for Use when
preparing and administering Cabenuva. The suspensions should be injected slowly via
intramuscular injection and avoid accidental intravenous
administration. Observe patients briefly (approximately 10 minutes)
after the injection. If a post-injection reaction occurs, monitor
and treat as clinically indicated
Hepatotoxicity:
● Hepatotoxicity has been reported in patients
receiving cabotegravir or rilpivirine with or without known
pre-existing hepatic disease or identifiable risk
factors
● Patients with underlying liver disease or marked
elevations in transaminases prior to treatment may be at increased
risk for worsening or development of transaminase
elevations
● Monitoring of liver chemistries is recommended and
treatment with Cabenuva should be discontinued if hepatotoxicity is
suspected
Depressive Disorders:
● Depressive disorders (including depressed mood,
depression, major depression, mood altered, mood swings, dysphoria,
negative thoughts, suicidal ideation or attempt) have been reported
with Cabenuva or the individual
products
● Promptly evaluate patients with depressive
symptoms
Risk of Adverse Reactions or Loss of Virologic Response Due to Drug
Interactions:
● The concomitant use of Cabenuva and other drugs may result in known or
potentially significant drug interactions (see Contraindications
and Drug Interactions)
● Rilpivirine doses 3 and 12 times higher than the
recommended oral dosage can prolong the QTc
interval
● Cabenuva should be used with caution in combination
with drugs with a known risk of Torsade de
Pointes
Long-Acting Properties and Potential
Associated Risks with Cabenuva:
● Residual concentrations of cabotegravir and
rilpivirine may remain in the systemic circulation of patients for
prolonged periods (up to 12 months or longer). Select appropriate
patients who agree to the required monthly or every-2-month
injection dosing schedule because non-adherence could lead to loss
of virologic response and development of
resistance
● To minimize the potential risk of developing viral
resistance, it is essential to initiate an alternative, fully
suppressive antiretroviral regimen no later than 1 month after the
final injection doses of Cabenuva when dosed monthly and no later than 2
months after the final injections of Cabenuva when dosed every 2 months. If virologic
failure is suspected, switch the patient to an alternative regimen
as soon as possible
ADVERSE REACTIONS
● The most common adverse reactions (incidence
≥2%, all grades) with Cabenuva were injection site reactions, pyrexia,
fatigue, headache, musculoskeletal pain, nausea, sleep disorders,
dizziness, and rash.
●
The
most common injection site reactions (grades 1-3, ≥1%) were
pain/discomfort, nodules, induration, swelling,
erythema, pruritus,
bruising/discoloration, warmth, and hematoma
DRUG INTERACTIONS
●
Refer to the applicable
full Prescribing Information for important drug interactions
with Cabenuva, VOCABRIA, or EDURANT
●
Because Cabenuva is a complete regimen, coadministration with
other antiretroviral medications for the treatment of HIV-1
infection is not recommended
●
Drugs that are strong
inducers of UGT1A1 or 1A9 are expected to decrease the plasma
concentrations of cabotegravir. Drugs that induce or inhibit CYP3A
may affect the plasma concentrations of
rilpivirine
●
Cabenuva should be used with caution in combination
with drugs with a known risk of Torsade de
Pointes
USE IN SPECIFIC POPULATIONS
●
Pregnancy: There are insufficient human data on the use
of Cabenuva during pregnancy to adequately assess a
drug-associated risk for birth defects and miscarriage. Discuss the
benefit-risk of using Cabenuva during pregnancy and conception and consider
that cabotegravir and rilpivirine are detected in systemic
circulation for up to 12 months or longer after discontinuing
injections of Cabenuva. An Antiretroviral Pregnancy Registry has been
established
●
Lactation: The CDC recommends that HIV 1−infected
mothers in the United States not breastfeed their infants to avoid
risking postnatal transmission of HIV-1 infection. Breastfeeding is
also not recommended due to the potential for developing viral
resistance in HIV-positive infants, adverse reactions in a
breastfed infant, and detectable cabotegravir and rilpivirine
concentrations in systemic circulation for up to 12 months or
longer after discontinuing injections of Cabenuva
Please see full Prescribing
Information.
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 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 ViiV Healthcare's Patient Assistance Program
ViiV Healthcare is committed to providing assistance to eligible
people living with HIV in the US who need our medicines. ViiV
Healthcare's centralised service, ViiV Connect, provides
comprehensive information on access and coverage to help patients
living in the US get their prescribed ViiV Healthcare medicines
whether they are insured, underinsured or
uninsured. ViiV Connect provides
one-on-one support from dedicated access coordinators, as well as
having an integrated website, one site with many resources,
including a portal. For more information on ViiV Connect,
visit www.viivconnect.com.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
ViiV Healthcare enquiries:
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Media enquiries:
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Audrey Abernathy
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+1 919 605 4521
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(North Carolina)
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Catherine Hartley
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+44 7909 002 403
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(London)
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GSK enquiries:
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Media enquiries:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Madeleine Breckon
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+44 (0) 20 8047 5502
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(London)
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Kristen Neese
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+1 804 217 8147
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(Philadelphia)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Analyst/Investor enquiries:
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Nick Stone
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+44 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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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 in the Company's Annual Report on
Form 20-F for 2020, GSK's Q3 Results 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.
Cabenuva (cabotegravir, rilpivirine) Prescribing Information. US
Approval January 2022.
2. Overton
E, 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 randomized, multicentre, open-label,
phase 3b non-inferiority study. Lancet, 396(10267): 1994-2005. 9
December 2020. doi:
10.1016/S0140-6736(20)32666-0.
3.
Chounta, Vasiliki et al. "Patient-Reported Outcomes Through 1 Year
of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and
Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M)." The
patient, 10.1007/s40271-021-00524-0. 31 May. 2021,
doi:10.1007/s40271-021-00524-0
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: February
01, 2022
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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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