FDA Clears Self-injectable Belimumab (Benlysta) for SLE

Megan Brooks

July 21, 2017

The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of belimumab (Benlysta, GlaxoSmithKline) for treatment of adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.

"The approval marks the first subcutaneous self-injection treatment option for patients with SLE," GlaxoSmithKline said in a news release.

With training by their healthcare provider, patients will be able to administer belimumab as a once-weekly 200-mg injection from either a single-dose prefilled syringe or from a single-dose autoinjector.

Belimumab is a B-lymphocyte stimulator protein inhibitor that is thought to decrease the amount of abnormal B cells. It is hypothesized that an abnormal level of B cells is a mechanism of action in lupus. An intravenous (IV) formulation of belimumab was approved by the FDA in 2011.

"Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta. The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions," Vlad Hogenhuis, senior vice president of GlaxoSmithKline and head of specialty care, said in the release.

The subcutaneous formulation of belimumab will be available in specialty pharmacies in the United States in late August, the company said.

They note that the safety profile observed for belimumab when administered subcutaneously is consistent with the known safety profile of belimumab administered intravenously, with the exception of local injection-site reactions, which occurred in 6.1% of patients receiving belimumab in clinical trials.

The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, the company notes, nor has it been studied in combination with other biologics or IV cyclophosphamide. Use of belimumab is not recommended in these settings.

GlaxoSmithKline said full US prescribing information, including a medication guide, will be available online in the near future at www.gsksource.com. In the meantime, clinicians may request a copy through GlaxoSmithKline's communications office.

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