Posted by Michael Wonder on 26 Sep 2016
GSK announces regulatory submissions for subcutaneous formulation of Benlysta (belimumab) for patients with systemic lupus disease
23 September 2016 - GSK today 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.
The submissions comprise:
- A biologics licence application 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 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.
