- Benlysta is now the first and only biologic approved for adults
and children who have lupus or lupus nephritis
GSK plc (LSE/NYSE: GSK) today announced that the US Food and
Drug Administration (FDA) has approved Benlysta (belimumab) for the
treatment of children aged 5 to 17 with active lupus nephritis (LN)
who are receiving standard therapy. Lupus nephritis is a serious
inflammation of the kidneys caused by lupus, which can lead to
end-stage kidney disease, requiring dialysis or a kidney
transplant.i The approval extends the current indication in the US
to include both lupus and active LN for the intravenous formulation
in the pediatric patient population.
Please see US Prescribing Information for Benlysta.
This is the first FDA-approved treatment for pediatric LN, which
remains a driving factor in increased complications,
hospitalizations and mortality rates in childrenii. Prior to this,
treatment options for children were mainly limited to use of
non-selective immunosuppressants and corticosteroids.
“Active lupus nephritis is a potential serious complication in
children with lupus, with most cases occurring within the first two
years after their initial lupus diagnosis,” said Stevan W. Gibson,
President and CEO, Lupus Foundation of America. “This approval
marks a significant step forward in providing treatment options to
these children at risk of incurring kidney damage early on in
life.”
“The long-term goal of lupus nephritis management in adults and
children is to preserve renal function while minimizing
treatment-related toxicities and associated morbidity,” said Herson
Quinones, VP, Specialty and Pipeline US Medical Affairs, GSK. “This
Benlysta approval highlights GSK’s commitment to bring treatment
options to children living with lupus nephritis. This is another
example of how GSK continues to get ahead of this burdensome
disease by focusing on science and being grounded in over a decade
of clinical experience.”
Through ongoing research, GSK is committed to improving the
lives of those living with lupus and researching ways to prevent
organ and kidney damage in adults and children living with lupus
and active LN.
About lupus nephritis (LN)
Systemic lupus erythematosus (SLE), the most common form of
lupus, is a chronic, incurable, autoimmune disease associated with
a range of symptoms that can fluctuate over time including painful
or swollen joints, extreme fatigue, unexplained fever, skin rashes
and organ damage. In lupus nephritis (LN), SLE causes kidney
inflammation (swelling or scarring) of the small blood vessels that
filter wastes in your kidney (glomeruli) and sometimes the kidneys,
by attacking them like they would attack a disease.ii
LN can lead to end-stage kidney disease, which requires kidney
dialysis or a transplant. Despite improvements in both diagnosis
and treatment over the last few decades, LN remains an indicator of
poor prognosis.iii,iv Manifestations of LN include proteinuria,
elevations in serum creatinine and the presence of urinary
sediment.
About BENLYSTA (belimumab)
BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal
antibody that binds to soluble BLyS. BENLYSTA does not bind B cells
directly. By binding BLyS, BENLYSTA inhibits the survival of B
cells, including autoreactive B cells, and reduces the
differentiation of B cells into immunoglobulin-producing plasma
cells. First approved in 2011, it is the first and only approved
biologic for both SLE and LN in more than 50 years.
The following information is based on the US Prescribing
Information for BENLYSTA in licensed indications only. Please
consult the full Prescribing Information for all the labelled
safety information for BENLYSTA.
INDICATION
BENLYSTA is indicated for patients aged ≥5 with active systemic
lupus erythematosus (SLE) or active lupus nephritis who are
receiving standard therapy. BENLYSTA is not recommended in patients
with severe active central nervous system lupus.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.
WARNINGS AND PRECAUTIONS
Serious Infections: Serious and sometimes fatal
infections have been reported and occurred more frequently with
BENLYSTA. Use caution in patients with severe or chronic
infections, and consider interrupting therapy in patients with a
new infection.
Progressive Multifocal Leukoencephalopathy
(PML): Cases of JC virus-associated PML resulting in
neurological deficits, including fatal cases, have been reported.
If PML is confirmed, consider stopping immunosuppressant therapy,
including BENLYSTA.
Hypersensitivity Reactions (Including Anaphylaxis): Acute
hypersensitivity reactions, including anaphylaxis and death, and
infusion-related reactions have been reported. Generally, reactions
occurred within hours of the infusion but may occur later,
including in patients who have previously tolerated BENLYSTA.
Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue,
myalgia, headache, and facial edema) typically occurred up to a
week after infusion. Monitor patients during and after treatment
and be prepared to manage anaphylaxis and infusion-related
reactions. Be aware of the risk of hypersensitivity reactions,
which may present as infusion-related reactions. Discontinue
immediately in the event of a serious reaction. With intravenous
administration, if an infusion reaction develops, slow or interrupt
the infusion.
Depression and Suicidality: Depression and suicidality
were reported in patients receiving BENLYSTA. Before adding
BENLYSTA, assess patients’ risk of depression and suicide and
monitor them during treatment. Instruct patients/caregivers to
contact their HCP if they experience new/worsening depression,
suicidal thoughts/behavior, or other mood changes.
Malignancy: There is an increased risk of malignancies
with the use of immunosuppressants. The impact of BENLYSTA on the
development of malignancies is unknown.
Immunization: Live vaccines should not be given for 30
days before or concurrently with BENLYSTA as clinical safety has
not been established.
Use With Biologic Therapies: BENLYSTA has not been
studied and is not recommended in combination with other biologic
therapies, including B-cell targeted therapies.
ADVERSE REACTIONS
The most common serious adverse reactions in adult SLE clinical
trials were serious infections; some were fatal. The most common
adverse reactions (≥5%) were nausea, diarrhea, pyrexia,
nasopharyngitis, bronchitis, insomnia, pain in extremity,
depression, migraine, pharyngitis, and injection site reactions
(subcutaneous injection).
Adverse reactions reported in clinical trials with SLE pediatric
patients (≥5 years) and adult patients with lupus nephritis were
consistent with those observed in adult SLE trials.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are insufficient data in pregnant women
to establish whether there is drug-associated risk for major birth
defects or miscarriage. After a risk/benefit assessment, if
prevention is warranted, women of childbearing potential should use
contraception during treatment and for ≥4 months after the final
treatment.
Pregnancy Registry: HCPs are
encouraged to register patients and pregnant women are encouraged
to enroll themselves by calling 1-877-681-6296.
About GSK
GSK is a global biopharma company with a purpose to unite
science, technology, and talent to get ahead of disease together.
Find out more at gsk.com/company
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 2021, GSK’s Q1 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
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Registered Office:
980 Great West Road Brentford, Middlesex TW8 9GS
i National Institute of Diabetes and Digestive and Kidney
Diseases. Lupus and Kidney Disease (Lupus Nephritis). Available at
www.niddk.nih.gov/health-information/kidney-disease/lupus-nephritis
ii Ardoin, S.P., Daly, R., Merzoug, L. et al. Research priorities
in childhood-onset lupus: results of a multidisciplinary
prioritization exercise. Pediatr Rheumatol 2019; 17, 32. iii
National Kidney Foundation, Lupus and Kidney Disease (Lupus
Nephritis). Available at www.kidney.org/atoz/content/lupus iv
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. v Waldman M and Appel GB. Update of the
Treatment of Lupus Nephritis. Kidney International
2006;70:1403-1412.
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