A European panel has recommended approval of a self-injectable reformulated version of Benlysta (belimumab) as an adjunct therapy for certain adults with systemic lupus erythematosus (SLE).
Glaxo Smith Kline (GSK) said in a release that the European Medicines Agency’s Committee for Medicinal Products for Human Use made its recommendation to the European Commission following results of a phase III study of its reformulated Benlysta performed earlier this year.
Benlysta previously was licensed in Europe as a treatment to be administrated by health care professionals in hospitals or clinics, the release said.
GSK’s application seeks approval for Benlysta as a self-injectable treatment in two formulations: as a prefilled syringe and as an auto-injector, both in single-dose amounts, the release said.
“Today’s important recommendation takes us a step closer to making a second formulation of Benlysta available to health care professionals and patients across Europe,” Vlad Hogenhuis, GSK sevior vice president and head of specialty care, said in the release. “We look forward to receiving a final decision from the European Commission in the coming months.”
Once approved, the formulation will let patients self-administer at home, the release said.
Benlysta was engineered to help patients with active autoantibody-positive (SLE) who exhibit a high degree of disease activity regardless of regular therapy, the release said.