REG - GlaxoSmithKline PLC - Benlysta approved in China for Lupus Nephritis

GSKAnnouncement

10/02/2022 09:00

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RNS Number : 2838B  GlaxoSmithKline PLC  10 February 2022

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 (https://www.gsk.com/en-gb/about-us/) .

 

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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.

 

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 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]

 

 

 

 

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