Regulatory Affairs

GSK receives FDA approval for self-injectable Benlysta formulation

Published 24 July 2017

GSK has secured approval from the US Food and Drug Administration (FDA) for a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive Systemic Lupus Erythematosus (SLE), who are receiving standard therapy.

The FDA approval marks the first subcutaneous self-injection treatment option for patients with SLE, the most common form of lupus – a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body.

After completing training, patients will be able to administer the medicine as a weekly injection of 200 mg, from either a single-dose prefilled syringe or from a single-dose autoinjector.

This is the second formulation of Benlysta to be granted FDA approval for SLE. Earlier, the intravenous (IV) formulation was approved in 2011, which is administered by healthcare professionals to patients as a weight-based dose of 10mg/kg, through a one-hour infusion in a hospital or clinic every four weeks, after an initial loading phase on days 0, 14 and 28.

The FDA granted approval for the subcutaneous formulation based on data from the BLISS-SC phase III pivotal study of more than 800 patients with active SLE.

The study measured reduction in disease activity at week 52 in patients receiving belimumab plus standard of care, compared to patients receiving placebo plus standard of care. The assessment was done using the Systemic Lupus Erythematosus Responder Index (SRI), a composite measure of efficacy in lupus.

The Benlysta subcutaneous formulation will be available in specialty pharmacies in the US from August. Further regulatory filings in other countries are planned during the course of 2017.

Benlysta is licensed in the European Union (EU) as an add-on therapy in adult patients with active autoantibody-positive SLE. The subcutaneous formulation is currently not approved in the EU.