Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe
LONDON, UK I October 29, 2019 I GlaxoSmithKline plc today announced that the European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK said: “Children with lupus typically have more severe disease and earlier onset of organ damage than adults, but until now their treatment options have been limited. This approval means that for the first time in Europe these children can be treated with a biologic therapy specifically developed and approved for their disease.”
Alain Cornet, General Secretary of Lupus Europe, a charity supporting people with lupus in Europe, commented: “This decision is great news for the lupus community in Europe and particularly for young people affected and their supportive families, that so much need new therapeutic options. We are thankful to the many patients who, by taking part in clinical trials, made such progress possible.”
There are estimated to be between 3,000 and 6,000 children aged five to 17 years old with systemic lupus erythematosus in the European Union.[1] In children this disease is associated with more rapid accrual of damage and has a higher degree of morbidity compared with systemic lupus erythematosus in adult populations.[2,3]
This approval by the European Commission follows recent approvals in the US and Japan[4,5], all supported by data from PLUTO, a post-approval commitment study.
About systemic lupus erythematosus (SLE)
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. SLE is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide.[6]
About the PLUTO study
The PLUTO (Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy) study assessed the efficacy, safety and pharmacokinetics of 10 mg/kg IV belimumab plus standard therapy compared with placebo plus standard therapy for one-year in 93 children aged 5 – 11 years (n=13,) and 12 – 17 years (n=80) with SLE.
The benefit/risk profile and pharmacokinetics of IV belimumab in childhood-onset SLE were found to be generally consistent with adult SLE.[7] The proportion of children achieving a clinically meaningful improvement in disease activity, as assessed by the SLE responder index response rate, was numerically higher in patients receiving belimumab plus standard therapy (52.8%) compared with placebo plus standard therapy (43.6%) at Week 52.[7]
The proportion of patients experiencing at least one adverse event (AE) and a serious AE was 79.2% and 17.0% for the belimumab group compared to 82.5% and 35.0% for the placebo group, respectively. No new safety signals were observed in the paediatric population 12 years of age and above (n=80). Safety data in children younger than 12 years of age (n=13) are limited. [7]
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.
Benlysta is currently the only medicine specifically developed and approved for SLE for adults in Europe. It was approved as an IV formulation in July 2011, and as a subcutaneous (SC) formulation in November 2017. Benlysta IV approval has now been extended to children.
IV Benlysta is indicated in the European Union as add-on therapy in patients aged 5 years and older 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.
The Benlysta subcutaneous formulation is not approved for use in children in the EU or elsewhere in the world.
The updated EU Summary of Product Characteristics for Benlysta is available on: www.ema.europa.eu
The IV formulation of Benlysta was first approved for use in children five years and older in the US in April 2019.[4,5] It was also approved in this age group in Japan in September 2019 and regulatory submissions are ongoing in other parts of the world.
Benlysta is indicated in the US for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy: Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.
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
GSK’s commitment to immunology
GSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and paediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.
Serving paediatric patients
We are committed to bringing our specialty biologic medicines to paediatric patients who have limited treatment options. In addition to this approval, we have achieved regulatory approval in the US and Europe of a different medicine for children with severe eosinophilic asthma, reinforcing our commitment to serving an unmet need with these medicines that are proven to be effective in adults.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Trademarks are owned by or licensed to the GSK group of companies.
References
- GSK data on file, Characterizing the burden of childhood-onset Systemic Lupus Erythematosus (SLE) in the United States and European Union. DoF Summary DNG # 2019N415028_00. August 2019.
- Brunner HI et al. Difference in disease features between childhood-onset and adult-onset systemic lupus erythematosus. Arthritis Rheum 2008;58(2):556–62.
- Tucker LB et al. Adolescent onset of lupus results in more aggressive disease and worse outcomes: results of a nested matched case-control study within LUMINA, a multiethnic US cohort (LUMINA LVII). Lupus 2008;17(4):314–22.
- FDA approves first treatment for pediatric patients with lupus. Press Release April 26, 2019.
- GSK receives US approval of Benlysta for intravenous use in children with lupus aged five years and above. Press Release April 26, 2019.
- Lupus Foundation of America. What is lupus? Available at: https:// resources.lupus.org/entry/what-is-lupus Last accessed March 2019
- Brunner H et al. Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus. American College of Rheumatology 2018 Abstract 2867.
SOURCE: GlaxoSmithKline
Post Views: 46
Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe
LONDON, UK I October 29, 2019 I GlaxoSmithKline plc today announced that the European Commission has adopted a decision to extend to children five years and older, the existing adult indication for intravenous Benlysta (belimumab) as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK said: “Children with lupus typically have more severe disease and earlier onset of organ damage than adults, but until now their treatment options have been limited. This approval means that for the first time in Europe these children can be treated with a biologic therapy specifically developed and approved for their disease.”
Alain Cornet, General Secretary of Lupus Europe, a charity supporting people with lupus in Europe, commented: “This decision is great news for the lupus community in Europe and particularly for young people affected and their supportive families, that so much need new therapeutic options. We are thankful to the many patients who, by taking part in clinical trials, made such progress possible.”
There are estimated to be between 3,000 and 6,000 children aged five to 17 years old with systemic lupus erythematosus in the European Union.[1] In children this disease is associated with more rapid accrual of damage and has a higher degree of morbidity compared with systemic lupus erythematosus in adult populations.[2,3]
This approval by the European Commission follows recent approvals in the US and Japan[4,5], all supported by data from PLUTO, a post-approval commitment study.
About systemic lupus erythematosus (SLE)
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. SLE is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide.[6]
About the PLUTO study
The PLUTO (Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy) study assessed the efficacy, safety and pharmacokinetics of 10 mg/kg IV belimumab plus standard therapy compared with placebo plus standard therapy for one-year in 93 children aged 5 – 11 years (n=13,) and 12 – 17 years (n=80) with SLE.
The benefit/risk profile and pharmacokinetics of IV belimumab in childhood-onset SLE were found to be generally consistent with adult SLE.[7] The proportion of children achieving a clinically meaningful improvement in disease activity, as assessed by the SLE responder index response rate, was numerically higher in patients receiving belimumab plus standard therapy (52.8%) compared with placebo plus standard therapy (43.6%) at Week 52.[7]
The proportion of patients experiencing at least one adverse event (AE) and a serious AE was 79.2% and 17.0% for the belimumab group compared to 82.5% and 35.0% for the placebo group, respectively. No new safety signals were observed in the paediatric population 12 years of age and above (n=80). Safety data in children younger than 12 years of age (n=13) are limited. [7]
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.
Benlysta is currently the only medicine specifically developed and approved for SLE for adults in Europe. It was approved as an IV formulation in July 2011, and as a subcutaneous (SC) formulation in November 2017. Benlysta IV approval has now been extended to children.
IV Benlysta is indicated in the European Union as add-on therapy in patients aged 5 years and older 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.
The Benlysta subcutaneous formulation is not approved for use in children in the EU or elsewhere in the world.
The updated EU Summary of Product Characteristics for Benlysta is available on: www.ema.europa.eu
The IV formulation of Benlysta was first approved for use in children five years and older in the US in April 2019.[4,5] It was also approved in this age group in Japan in September 2019 and regulatory submissions are ongoing in other parts of the world.
Benlysta is indicated in the US for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy: Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of Benlysta is not recommended in these situations.
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
GSK’s commitment to immunology
GSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and paediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.
Serving paediatric patients
We are committed to bringing our specialty biologic medicines to paediatric patients who have limited treatment options. In addition to this approval, we have achieved regulatory approval in the US and Europe of a different medicine for children with severe eosinophilic asthma, reinforcing our commitment to serving an unmet need with these medicines that are proven to be effective in adults.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.
Trademarks are owned by or licensed to the GSK group of companies.
References
- GSK data on file, Characterizing the burden of childhood-onset Systemic Lupus Erythematosus (SLE) in the United States and European Union. DoF Summary DNG # 2019N415028_00. August 2019.
- Brunner HI et al. Difference in disease features between childhood-onset and adult-onset systemic lupus erythematosus. Arthritis Rheum 2008;58(2):556–62.
- Tucker LB et al. Adolescent onset of lupus results in more aggressive disease and worse outcomes: results of a nested matched case-control study within LUMINA, a multiethnic US cohort (LUMINA LVII). Lupus 2008;17(4):314–22.
- FDA approves first treatment for pediatric patients with lupus. Press Release April 26, 2019.
- GSK receives US approval of Benlysta for intravenous use in children with lupus aged five years and above. Press Release April 26, 2019.
- Lupus Foundation of America. What is lupus? Available at: https:// resources.lupus.org/entry/what-is-lupus Last accessed March 2019
- Brunner H et al. Efficacy and Safety of Intravenous Belimumab in Children with Systemic Lupus Erythematosus. American College of Rheumatology 2018 Abstract 2867.
SOURCE: GlaxoSmithKline
Post Views: 46
