Type of information: Granting of a Market Authorisation in the US
Product name: Benlysta®
Therapeutic area: Autoimmune diseases
- monoclonal antibody. Belimumab is a B Lymphocyte Stimulator (BLyS)-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptor on B-cells. Belimumab does not bind B-cells directly, but 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.
Company: GSK (UK) Human Genome Sciences (USA)
Disease: systemic lupus erythematosus (SLE)
- • On July 21, 2017, GSK announced that the FDA has approved a new subcutaneous formulation of Benlysta® (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus who are receiving standard therapy. The approval marks the first subcutaneous self-injection treatment option for patients with SLE. This is the second formulation of Benlysta to be granted approval for SLE, adding to the existing intravenous formulation, approved in 2011, which is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, via a one-hour infusion in a hospital or clinic setting every four weeks (following an initial loading phase given on days 0, 14 and 28).
- The approval is based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE, which 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 subcutaneous formulation will be available in specialty pharmacies in the US in late August.
- • On September 23, 2016, GSK announced that it has filed regulatory submissions in the US and Europe for Benlysta® (belimumab) for approval as a subcutaneous formulation in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). The submissions comprise:
- - A Biologics Licence Application (BLA) to the FDA for belimumab administered subcutaneously for the treatment of adult patients with active, autoantibody?positive SLE who are receiving standard therapy
- - An extension Marketing Authorisation Application (MAA) to the European Medicines Agency for belimumab administered subcutaneously as 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.
- The regulatory submissions for the subcutaneous formulation in the US and Europe are based on results from the BLISS-SC Phase III pivotal study, which evaluated belimumab 200mg administered weekly via subcutaneous injection plus standard of care (SoC) compared to placebo plus SoC, in patients with active autoantibody-positive SLE. The BLA and extension MAA are seeking approval for the Benlysta subcutaneous formulation in 2 presentations, a single-dose prefilled syringe and a single-dose autoinjector. Regulatory filings in other countries are planned during the course of 2016 and 2017. The subcutaneous formulation of Benlysta® is currently not approved for use anywhere in the world.
- • On May 20, 2011, the CHMP has adopted positive opinion recommending the granting of marketing autorisation to Benlysta® (belimumab), intended as add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus with a high degree of disease activity.
- • On 13th July 2011, belimumab was approved by the European Commission . It is indicated as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. The summary of product characteristics (SmPC) lists patient groups which have not been studied with belimumab, including severe active CNS lupus or severe active lupus nephritis. Use of belimumab is therefore not recommended to treat these conditions. Caution should be exercised if belimumab is co-administered with other B cell targeted therapy or intravenous cyclophosphamide, as it has not been studied in combination with these agents.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-03-09/2017-07-21
UE authorization: 2011-07-13
Favourable opinion UE: 2011-05-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: