a2840b
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
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reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
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as permitted by Regulation S-T Rule 101(b)(1): ____
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Issued: 10 February 2022, London UK
China's
National Medical Products Administration approves Benlysta
(belimumab) for adult patients with active lupus nephritis
●
First
and only biologic approved in China for both systemic lupus
erythematosus and lupus nephritis
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that China's
National Medical Products Administration (NMPA) has
approved Benlysta (belimumab) for the treatment of adult
patients with active lupus nephritis (LN) who are receiving
standard of care. The approval extends the current indication in
China as add-on therapy in adults and children aged five years and
older with active systemic lupus erythematosus (SLE). This approval
makes belimumab China's first and only biologic medicine approved
for SLE and LN.
Dr Hal Barron, Chief Scientific Officer, and President R&D, GSK
said: "Nearly 500,000
people in China have systemic lupus erythematosus and more than
half of these patients will develop one of the most common and
serious complications, lupus nephritis.[i],[ii] Recognising
that lupus nephritis can lead to kidney damage, this approval will
allow patients in China access to a new treatment option to help
slow the progressive nature of systemic lupus."
The NMPA approval is based on data from the BLISS-LN (Efficacy and
Safety of Belimumab in Adult Patients with Active Lupus Nephritis)
phase III trial, which showed that over two years, belimumab
added to standard therapy increased renal response rates and helped
to reduce the risk of worsening of kidney disease in patients with
active LN compared to standard of care alone.
Since December 2020, belimumab has been approved for active LN by
16 regulatory bodies around the world, including the U.S. Food and
Drug Administration, European Medicines Agency, and NMPA. In
addition, belimumab is approved in 60 countries for SLE, and
approved and available for use for both SLE and LN in more than 25
countries worldwide to date, underscoring a robust body of evidence
to support its use in patients around the world.
Professor Xueqing Yu, President of Guangdong Provincial People's
Hospital and principal BLISS-LN investigator,
said: "With more than half
of systemic lupus erythematosus patients experiencing some degree
of renal involvement, the approval of belimumab is a much-needed
new treatment option. Not only can belimumab help preserve the
kidneys, but it can also facilitate a reduction in doses of
steroids and immunosuppressants, which can have toxic side effects
and lead to organ damage."
The BLISS-LN phase III trial is the largest and longest trial
conducted in active LN, involving 448 adult patients. The trial met
its primary endpoint, demonstrating that a statistically
significant and clinically meaningful greater number of patients
achieved Primary Efficacy Renal Response (PERR) at two years (or
104 weeks) when treated with belimumab plus standard of care
compared to placebo plus standard of care in adults with active LN
(43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311).
Statistical significance compared to placebo across all four major
secondary endpoints was achieved, including complete renal response
at week 104 and time to renal-related event or death. The adverse
reactions observed in BLISS-LN were consistent with the known
safety profile of belimumab administered intravenously plus
standard of care in patients with SLE.
Belimumab is also approved in China for five-year-old and older
patients with active, autoantibody-positive SLE with high disease
activity (e.g., positive anti-double-stranded DNA and low
complement, and an objective assessment of overall disease activity
using SELENA-SLEDAI score ≥ 8) in combination with standard
of care. It is also the first biologic in China's 2021 National
Reimbursement Drug List for paediatric SLE.
About the BLISS-LN trial
BLISS-LN
is a phase III, 104-week, randomised, double-blind,
placebo-controlled, post-approval commitment trial to evaluate the
efficacy and safety of intravenous (IV) belimumab 10mg/kg plus
standard of care (mycophenolate mofetil for induction and
maintenance, or cyclophosphamide for induction followed by
azathioprine for maintenance, plus steroids) compared to placebo
plus standard of care in adult patients with active LN. Active LN
was confirmed by renal biopsy during screening visit using the 2003
International Society of Nephrology/Renal Pathology Society
criteria within the past six months, and clinically active kidney
disease requiring induction therapy.[i]
About lupus
The
most common form of lupus is SLE, a chronic, incurable, autoimmune
disease. It is difficult to diagnose and even more challenging to
treat. The condition is associated with a range of debilitating
symptoms that can fluctuate over time, including painful or swollen
joints, extreme fatigue, unexplained fever, and skin rashes. In LN,
SLE causes inflammation (swelling or scarring) of the small blood
vessels that filter wastes in the kidney (glomeruli) and sometimes
the kidneys by attacking them like they would attack a
disease.[ii] LN can lead
to end-stage kidney disease, requiring dialysis or a kidney
transplant. Despite improvements in diagnosis and treatment over
the last few decades, LN remains an indicator of poor
prognosis.[iii],[iv] Manifestations
of LN include proteinuria, elevated serum creatinine levels, and
urinary sediment. Approximately 20% of patients with LN progress to
end-stage kidney disease within ten years of diagnosis.[v]
About Benlysta (belimumab)
Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)
specific inhibitor, is a human monoclonal antibody that binds to
soluble BLyS. Belimumab does not bind to B cells directly
or directly deplete B cell populations. By binding BLyS, belimumab
inhibits the survival of B cells, including autoreactive B cells,
and reduces the differentiation of B cells into
immunoglobulin-producing plasma cells.
In
China, belimumab was approved for add-on treatment of adults
with SLE as an IV formulation in July 2019 and for children aged
five years and above in December 2020.
Benlysta China Indication
Benlysta,
combined with standard therapy, is indicated as therapy in patients
aged 5 years and older with active, autoantibody-positive systemic
lupus erythematosus (SLE) with a high disease activity (e.g.,
positive anti-dsDNA and low complement, SELENA-SLEDAI
score≥8) despite standard therapy.
Benlysta,
combined with standard therapy, is indicated in adult patients with
active lupus nephritis.
IMPORTANT SAFETY INFORMATION
The following Important Safety Information is based on the China
Product Information. Please consult the full Product Information
for all the labelled safety information
for Benlysta (belimumab).
Contraindications
Hypersensitivity to belimumab or any excipients.
Warnings and precautions
Benlysta has not been
studied in patients with severe active central nervous system
lupus, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency
(IgA <10 mg/dl), patients with a history of major organ
transplant or hematopoietic stem/cell/marrow transplant or renal
transplant, patients with HIV, or patients with a history of, or
current, hepatitis B or C.
Caution: If Benlysta co-administered with other B cell targeted
therapy.
Infusion reactions and hypersensitivity: Administration may result in
hypersensitivity reactions and infusion reactions which can be
severe, and fatal. In the event of a severe reaction,
administration must be interrupted and appropriate medical therapy
administered. Risk of hypersensitivity reactions is greatest with
the first two doses; however, the risk should be considered for
every dose. Advise patients reactions are possible on day of, or
several days after. Delayed-type, non-acute hypersensitivity
reactions (e.g. rash, nausea, fatigue, myalgia, headache, facial
oedema) possible.
Benlysta IV: Infusions
should be administered by qualified healthcare professional trained
to give infusion therapy. Severe or life-threatening
hypersensitivity reactions and infusion reactions can occur,
possibly after several hours and can recur after initial treatment
of symptoms. Administer in an environment where resources for
managing reactions are available. Clinical supervision required for
several hours after infusion, following at least first 2 infusions.
Make patients aware of potential risk of hypersensitivity reactions
(day of, or several days after infusion, including signs/symptoms
and recurrence) and provide package leaflet each time Benlysta
administered. Premedication: An antihistamine, with/without
an antipyretic, may be administered.
Infections: Increased risk
of infections, including opportunistic. Younger children may be at
increased risk. Fatal infections (e.g. pneumonia and sepsis)
occurred more frequently in patients
receiving Benlysta; consider pneumococcal vaccination prior to
initiation. Do not initiate with active serious infections
(including serious chronic); exercise caution and assess
risk/benefit in patients with history of recurrent infection.
Carefully monitor new infections - consider interrupting
immunosuppressants including Benlysta until infection
resolved.
Depression and suicidality:
Before treatment assess risk of depression and suicide in patient;
closely monitor during treatment - consider discontinuation if new
or worsening psychiatric symptoms.
Progressive multifocal leukoencephalopathy: Monitor for new or worsening signs/symptoms
- refer to neurologist if suspected; suspend further dosing until
excluded.
Immunisation: Do not give
live vaccines 30 days before, or concurrently
with Benlysta.
Malignancy: May be increased risk with immunomodulatory medicines
including Benlysta.
Pregnancy and lactation
Women of childbearing potential must use effective contraception
during Benlysta treatment and for at least 4 months after
the last treatment. Limited data on use in pregnant women. Should
not be used unless the potential benefit justifies the potential
risk to the foetus. Not known whether Benlysta is excreted in human milk or absorbed
systemically after ingestion. Maternal IgG is secreted in breast
milk so recommended to either discontinue Benlysta or breast feeding depending on the
risk/benefit to mother and child.
Undesirable effects
Very common
(≥1/10): Bacterial
infections (e.g. bronchitis, urinary tract infections), diarrhoea,
nausea. Common (≥1/100 to
<1/10): Gastroenteritis
viral, pharyngitis, nasopharyngitis, viral upper respiratory tract
infection, leucopenia, hypersensitivity reactions, depression,
migraine, injection site reactions, pain in extremity, infusion or
injection-related systemic reactions,
pyrexia. Serious: Anaphylactic reaction, suicidal ideation and
behaviour. Paediatric population (IV
Benlysta): no new safety
signals in ≥12-year olds.
GSK's commitment to people living with lupus
GSK is
focused on advancing treatment for people with lupus, one of the
most complex autoimmune diseases, building on decades of research
with a long-term commitment to innovative science. As the only
company with a biological treatment approved for both adults with
lupus and lupus nephritis, as well as paediatric lupus, GSK is
leading the way to help patients and their families manage this
chronic, inflammatory autoimmune disease throughout its course. Our
lupus experience stands strong on a wealth of clinical and
real-world evidence in the development of belimumab, and as leaders
in lupus we are investing and innovating for today and for the
future. We understand this disease can affect patients differently
and that many have unique needs. We strive for innovative ways to
bring treatments to those who need them while actively seeking
opportunities to partner with patients, advocates, and physicians
to inspire long-term goals that will help them feel hopeful for the
future.
About GSK
GSK is a science-led global healthcare company. For further
information please visit www.gsk.com/about-us.
GSK enquiries:
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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 Q4 Results and any
impacts of the COVID-19 pandemic.
Registered in England & Wales:
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Registered Office:
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Great West Road
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TW8
9GS
[i] Furie
R., Rovin BH, Houssiau F, et al. Two-Year, Randomized,
Controlled Trial of Belimumab in Lupus
Nephritis N Engl J
Med. 2020;383:1117-28.
[ii] National Kidney
Foundation, Lupus and Kidney Disease (Lupus Nephritis). Available
at https://www.kidney.org/atoz/content/lupus. Accessed December
2021.
[iii] Gordon C, Hayne D,
Pusey C, et al. European Consensus Statement on the Terminology
used in the Management of Lupus
Glomerulonephritis. Lupus. 2009;18:257-26.
[iv] Waldman M and Appel
GB. Update of the Treatment of Lupus
Nephritis. Kidney
International.
2006;70:1403-1412.
[v] Tektonidou MG,
Dasgupta A, Ward MM. Risk of end-stage renal disease in patients
with lupus nephritis, 1971-2015: a systematic review and Bayesian
meta-analysis. Arthritis
Rheumatology.
2016;68(6):1432-41. [p. 1436A]
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
10, 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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