FDA approves GSK's BENLYSTA as the first medicine for adult patients with active lupus nephritis in the US
LONDON, Dec. 17, 2020 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.
Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Approximately 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease. BENLYSTA is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease."
The FDA approval for adult patients with active LN follows a Breakthrough Therapy Designation and Priority Review and is based on the positive results of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study and the unmet need in this patient population. The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, involving 448 adult patients. The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) when treated with BENLYSTA plus standard therapy compared to placebo plus standard therapy 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 and Time to Renal-Related Event or Death. The safety results are consistent with the known safety profile of BENLYSTA.
Dr. Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes for Medical Research at Northwell Health and Lead Investigator of the BLISS-LN study, commented: "We have long aspired to enhance outcomes for patients with lupus nephritis. In the four decades I have been caring for people with lupus, we have not been able to achieve remission in more than just one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the BLISS-LN study show that BENLYSTA added to standard therapy not only increased response rates over two years, but it also prevented worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone. Therefore, it is gratifying to see the rewards of decades of research."
Dr. Brad Rovin, Director of the Division of Nephrology and Medical Director of the Center for Clinical Research Management at the Ohio State University Wexner Medical Center, commented: "The overarching goal in the management of patients with lupus nephritis is to delay the need for kidney replacement therapies, such as dialysis and transplantation. The BLISS-LN study not only demonstrated that the addition of BENLYSTA to standard therapy significantly increased the PERR, but also showed that patients had a 49% decrease in risk for experiencing a renal-related event. I'm encouraged by the progress we're making in lupus nephritis."
About the BLISS-LN study
For US Patients: Making our products affordable and accessible
About lupus nephritis (LN)
About BENLYSTA (belimumab)
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.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.
Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.
Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.
Infusion Reactions: Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.
Depression and Suicidality: In adult trials, psychiatric events were reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. 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, or other mood changes.
Malignancy: The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.
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.
In adult patients with active lupus nephritis, serious infections occurred in 14% of patients receiving BENLYSTA IV (placebo 17%), some of which were fatal infections, BENLYSTA 0.9% (placebo 0.9%). Adverse reactions occurring in ≥3% of adults and ≥1% more than placebo were consistent with the known safety profile of BENLYSTA IV in SLE patients.
Adverse reactions in pediatric patients aged ≥5 years receiving BENLYSTA IV were consistent with those observed in adults.
The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.
USE IN SPECIFIC POPULATIONS
Pregnancy Registry: HCPs are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.
Lactation: No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness have not been established for BENLYSTA IV in SLE patients <5 years of age, and in active LN patients <18 years of age, and for BENLYSTA SC in SLE and LN patients <18 years of age.
GSK's commitment to immunology
Cautionary statement regarding forward-looking statements
Registered in England & Wales:
1 National Kidney Foundation, Lupus and Kidney Disease (Lupus Nephritis). Available at https://www.kidney.org/atoz/content/lupus
View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-approves-gsks-benlysta-as-the-first-medicine-for-adult-patients-with-active-lupus-nephritis-in-the-us-301195182.html
SOURCE GlaxoSmithKline (GSK)
Company Codes: LSE:GSK, NYSE:GSK