Issued: London, UK
GSK today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval for a new subcutaneous formulation of Benlysta (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus(SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy. SLE is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body.
Benlysta is a human monoclonal antibody which has been licensed as an intravenous treatment for SLE in Europe since 2011. In this form, it is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg via a one-hour infusion in a hospital or clinical setting every four weeks (following an initial loading phase given on days 0, 14 and 28).
Vlad Hogenhuis, Senior Vice President, Head of Specialty Care, GSK said, “Today’s important recommendation takes us a step closer to making a second formulation of Benlysta available to healthcare professionals and patients across Europe. If approved, it will allow patients to self-administer their medicine at home as a once weekly injection, providing additional choice to help meet the needs of individuals living with this complex and unpredictable disease. We look forward to receiving a final decision from the European Commission in the coming months.”
The positive opinion was based on results from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, published earlier this year in Arthritis & Rheumatology. The study measured reduction in disease activity at Week 52 in patients receiving belimumab plus standard of care, versus those receiving placebo plus standard of care (assessed by SRI, a composite measure of efficacy in lupus).
The regulatory submission is seeking approval for Benlysta subcutaneous formulation in two presentations, a single-dose prefilled syringe and a single-dose autoinjector. A final decision on approval will be made by the European Commission, which is anticipated in the next two to three months.
The Benlysta subcutaneous formulation is currently only approved for use in the US; approved in July 2017. Further regulatory submissions are under review or planned in other countries during the course of 2017. The Benlysta intravenous formulation is licensed for use in over 70 countries worldwide, including the US and EU countries.
About Benlysta (belimumab), for injection, for intravenous use only
Benlysta is currently the only medicine specifically developed and approved for SLE. 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.
Benlysta is available as 120 mg in a 5-mL single-use vial and 400 mg in a 20-mL single-use vial for injection, for intravenous use only.
Benlysta is licensed in the European Union as an add-on therapy in adult patients with active autoantibody-positive SLE, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy.
For the EU Summary of Product Characteristics for Benlysta, please visit www.ema.europa.eu
Full US prescribing information including Medication Guide is available at: https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Benlysta/pdf/BENLYSTA-PI-MG.PDF
About systemic lupus erythematosus (SLE)
SLE is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. SLE 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.
Important Safety Information for belimumab
The following safety information is based on a summary of the European Summary of Product Characteristics for Benlysta for intravenous use. Please consult the full Summary of Product Characteristics for all the labelled safety information for Benlysta (belimumab).
Hypersensitivity to belimumab or any excipients.
Warnings and precautions:
Not recommended in patients with severe active central nervous system lupus, severe active lupus nephritis, HIV, history of/current hepatitis B or C, hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) and patients with a history of major organ transplant or hematopoietic stem/cell/marrow transplant or renal transplant.
Concomitant use with B cell targeted therapy or cyclophosphamide: Caution in patients receiving other B cell targeted therapy or cyclophosphamide.
Malignancies and lymphoproliferative disorders: Caution in patients with a history of malignancy or who develop malignancy whilst receiving treatment.
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 infusions; however the risk should be considered for every infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Premedication including an antihistamine, with or without antipyretic, may be administered before infusion of Benlysta. There is insufficient knowledge to determine whether premedication could diminish the frequency or severity of infusion reactions. Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered. Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed. Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available. Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction. Patients should be advised that hypersensitivity reactions are possible on the day of, or the day after infusion, and be informed of potential signs and symptoms and the possibility of recurrence. Patients should be instructed to seek immediate medical attention if they experience any of these symptoms. The package leaflet should be provided to the patient each time Benlysta is administered. Delayed-type, non-acute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial oedema.
Infections: The mechanism of action of Benlysta could increase the potential risk of infections, including opportunistic infections and may interfere with the response to immunisations. Severe infections, including fatal cases, have been reported in SLE patients receiving belimumab. Exercise caution when considering use in patients with chronic infections or a history of recurrent infection. Do not use in patients receiving therapy for chronic infection. Patients who develop an infection while undergoing treatment with Benlysta should be monitored closely and careful consideration given to interrupting therapy until the infection is resolved.
Progressive multifocal leukoencephalopathy: There have been reports of progressive multifocal leukoencephalopathy (PML). Be alert to symptoms that patients may not notice e.g cognitive, neurological or psychiatric symptoms or signs. Monitor for any new or worsening symptoms or signs and if these occur, refer to a neurologist. Suspend further dosing if PML is suspected until it is exlcluded.
Immunisation: Live vaccines should not be given for 30 days before, or concurrently with Benlysta
Pregnancy and lactation:
Limited data on use in pregnant women. Not to be used unless clearly necessary. Not known whether Benlysta is excreted in human milk or absorbed after ingestion. Maternal IgG is secreted in breast milk so recommended to either discontinue Benlysta or breast feeding.
Very common: Bacterial infections (e.g. bronchitis, cystitis), diarrhoea, nausea. Common: Gastroenteritis viral, pharyngitis, nasopharyngitis, leucopenia, hypersensitivity reactions, depression, insomnia, migraine, pain in extremity, infusion-related reactions, pyrexia. Uncommon: Anaphylactic reaction, angioedema, urticaria, rash. Rare: Delayed-type, non-acute hypersensitivity reactions. See Summary of Product Characteristics for full details.
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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 under Item 3.D ‘Principal risks and uncertainties’ in the company’s Annual Report on Form 20-F for 2016.