The FINANCIAL — GSK on September 23 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 US Food and Drug Administration 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.
Benlysta is a human monoclonal antibody which is currently licensed for use intravenously as a one-hour infusion every four weeks1. 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, according to GSK.
Paul-Peter Tak, Chief Immunology Officer and Senior Vice President Research & Development Pipeline said: “Lupus is a complex and debilitating disease, mainly affecting women of working age, and its symptoms and impact vary from person to person. If approved, a subcutaneous formulation of Benlysta would provide an alternative approach to treatment administration, helping to address the individual needs of lupus patients.”
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.
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