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FDA approves self-injectable formulation of Benlysta for lupus
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The FDA has approved a self-injectable formulation of Benlysta for patients with systemic lupus erythematosus, according to a company press release.
“We are delighted with today’s decision,” Vlad Hogenhuis, senior vice president and head of specialty care at GlaxoSmithKline, said in the release. “Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms.
According to the release, this is the first approval for a subcutaneous self-injection treatment for patients with lupus. After instruction from their health care providers, patients will be able to self-administer once-weekly injections of 200 mg, either from a prefilled syringe or autoinjector. Previously, Benlysta (belimumab, GlaxoSmithKline) was approved as an intravenous formulation in 2011 to be administered by health care professionals at a dose of 10 mg/kg once every 4 weeks, after an initial phase of administration on days 0, 14 and 28.
The approval used data from the BLISS-SC phase 3 study of more than 800 patients with active lupus. The study demonstrated efficacy according to systemic lupus erythematosus index score after 52 weeks in patients who received belimumab plus standard care vs. those who received placebo plus standard care. Subcutaneous doses of Benlysta reportedly will become available in U.S. pharmacies in late August.
“Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta,” Hogenhuis said. “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.”
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Mary K. Crow, MD
This news provides another option to make it easier for patients. It offers flexibility and patients — if they choose — can administer the drug themselves at home. Every patient is different. Some patients like to come in and receive the drug in a medical setting, whether it is in a hospital or an infusion unit. They just find it works better for them. Other patients, who are more comfortable with injecting themselves, much prefer to do it at home for convenience reasons. This new option allows for flexibility for patients and rheumatologists, ensuring that patients receive this drug in a way that works best for them.
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