a9412f
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 March 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): ____
Issued: 24 March 2022, London UK
ViiV Healthcare announces label update
for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be
initiated with or without an oral lead-in
period
US FDA approval of updated label streamlines the initiation process
for the first and only complete long-acting HIV treatment by
allowing people to start directly with injections
London, 24 March 2022 -
ViiV Healthcare, the global specialist HIV company majority owned
by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi
Limited as shareholders, today announced that the US Food and Drug
Administration (FDA) approved a label update
for Cabenuva (cabotegravir, rilpivirine) making the oral
lead-in with cabotegravir and rilpivirine tablets optional. Oral
cabotegravir and rilpivirine can be taken for a month to assess
tolerability to the medicines prior to initiating cabotegravir and
rilpivirine injections, a
regimen co-developed as part of a collaboration with the Janssen
Pharmaceutical Companies of Johnson & Johnson, but this
oral lead-in is now
optional after clinical trial data demonstrated similar safety and
efficacy profiles for both initiation methods (with or without the
oral lead-in).1,
2
Cabenuva is the first and
only complete long-acting HIV treatment regimen and is approved in
the US as a once-monthly or every-two-month 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.
Lynn Baxter, Head of North America at ViiV Healthcare,
said: "Since
launching Cabenuva, we have been keenly focused on optimising the
user experience for both people living with HIV and healthcare
providers. Today's label update for the optional oral lead-in
provides a streamlined initiation process for the regimen by
allowing people to start directly on long-acting injections and
underscores ViiV Healthcare's ongoing commitment to providing
innovative treatment options that address the evolving needs of the
HIV community."
This US FDA approval is based on the FLAIR phase III trial Week-124
results, which showed there were similar outcomes regarding
maintenance of virologic suppression, safety, tolerability and
pharmacokinetics in people starting cabotegravir and rilpivirine
injections with or without the oral
lead-in. 2
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 Sciences Ireland Unlimited
Company. 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.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
Important Safety Information
for Cabenuva (cabotegravir 200mg/mL; rilpivirine
300mg/mL) 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
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: 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 GSK
GSK is a science-led global healthcare company. For further
information please visit https://www.gsk.com/en-gb/about-us.
ViiV Healthcare enquiries:
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Media
enquiries:
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Catherine
Hartley
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+44
7909 002 403
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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
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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Dan
Smith
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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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Analyst/Investor
enquiries:
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Nick
Stone
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+44 (0)
7717 618834
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(London)
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Sonya
Ghobrial
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+44 (0)
7392 784784
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(Consumer)
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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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Cautionary statement regarding forward-looking
statements
GlaxoSmithKline plc cautions investors that any forward-looking
statements or projections made by GlaxoSmithKline plc, 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
2021 and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
GlaxoSmithKline plc ViiV
Healthcare Limited
No.
3888792
No. 06876960
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
References
1. Cabenuva
(cabotegravir, rilpivirine) Prescribing Information. US
Approval March 2022.
2.
D'Amico R, Orkin C, Morell EB, et al. Safety and efficacy of
cabotegravir + rilpivirine long-acting with and without oral
lead-in: FLAIR Week 124 results. Presented at HIV Glasgow
2020.
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: March
24, 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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