Self-injectable belimumab receives FDA approval for systemic lupus erythematosus

GlaxoSmithKline announced on July 21 that it had received approval from the U.S. Food and Drug Administration for a new, self-injectable form of belimumab (Benlysta) for adult patients with systemic lupus erythematosus (SLE). Belimumab has previously been approved for SLE, in 2011, in an intravenous formulation.

The new formulation is the first self-injectable subcutaneous treatment available for patients with SLE. The previous treatment required 1 hour of intravenous infusion every 4 weeks, while the new treatment is 1 weekly injection.

Two of the 280 patients receiving placebo (0.7%) died during the study, as did 3 of the 556 patients receiving belimumab (0.5%). Serious infections occurred in 4.1% and 5.4% of patients receiving belimumab and placebo, respectively.

“The safety profile observed for Benlysta administered subcutaneously was consistent with the known safety profile of Benlysta administered intravenously, with the exception of local injection site reactions,” noted GlaxoSmithKline in its announcement. Each form of the drug has a risk of a reaction, whether an infusion reaction for IV administration or a hypersensitivity reaction for self-injection. A patient who reacted to the intravenous formulation with anaphylaxis is contraindicated for the self-injectable version.

It is not known what effect belimumab has on the risk of birth defects or miscarriage, so birth control is recommended for patients on the drug. Likewise, the effects of the drug on breast milk are not known. As belimumab may interfere with immunizations, a patient should not be vaccinated 30 days before or after taking the drug.

dwatson@frontlinemedcom.com