Self-Injectable Lupus Drug Receives FDA Approval

Lupus is what’s known as an autoimmune disease — that is, a disease in which the body produces antibodies that attack its own tissues. In the case of lupus, patients’ antibodies, which are produced by B cells, mistakenly attack the body’s own cells. In other words, the B cells are the major factor in the disease.

Consequently, a main goal of lupus researchers it to discover ways to correct the B-cell problem. One successful method has been a drug called belimumab, which is classified as a “B-lymphocyte stimulator protein inhibitor” and is thought to decrease the amount of abnormal B cells. In 2011, the U.S. Food and Drug Administration (FDA) approved an intravenous formulation of belimumab known as Benlysta. In its six years of existence, the FDA-approved intravenous formulation has been shown to be safe and effective. The major drawback, however, is that patients need to go regularly to hospitals or clinics to have the therapy administered.

A form of Benlysta newly approved by the FDA, however, might now eliminate the need for patients to leave home for belimumab therapy. This new subcutaneous formulation of Benlysta, which is manufactured by the pharmaceutical firm GlaxoSmithKline (GSK), is self-injectable. After users receive training from a health-care provider, they are able to administer the drug themselves once a week by using either a single-dose prefilled syringe or a single-dose autoinjector. The self-injectable Benlysta is available as 120 milligrams in a 5-milliliter single-dose vial and 400 milligrams in a 20-milliliter single-dose vial. According to Vlad Hogenhuis, Senior Vice President at GSK, “Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms. 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.”

Want to learn more about lupus? Read “Women With Lupus Can Fight Smart,” “How Moms Learn to Live With Lupus,” and “Bringing Lupus Center Stage.”

Joseph Gustaitis is a freelance writer and editor based in the Chicago area.

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