FDA Panel Recommends Benlysta, First New Treatment for Lupus in 50 Years
An advisory panel for the US Food and Drug Administration has voted 13 to 2 to recommend that the agency approve Benlysta, generic name belimumab made by Human Genome Sciences and GlaxoSmithKline, to treat lupus. Although the FDA is not required to follow the advisory panel’s recommendations, it usually does. If approved, Benlysta would be the first new treatment for lupus approved in over 50 years.
Belimumab Decreased Amount of Steroids Taken by Lupus Patients in Clinical Trials
Lupus is a chronic disease in which the patient’s immune system attacks the body’s organs and symptoms included inflammation, pain, and tissue damage. Belimumab is a monoclonal antibody designed to inhibit a protein called B-lymphocyte stimulator, or BlyS, responsible for mediating the maturation of antibody-producing beta cells that attack healthy tissue.
Clinical trials of the drug showed that patients only had a mild reduction in lupus symptoms compared to those taking a placebo, but an FDA statistician estimates that between seven and 10 patients who are on the drug could be expected to show some improvement.
Also, the addition of Benlysta decreased the amount of steroids that a patient took. Corticosteroids, one of three drugs currently used to treat lupus, greatly increase the risk of infection, weight gain, and high blood pressure.
Adverse effects were common, but were experienced by nearly all trial participants – whether taking belimumab or a placebo. These included headache, upper respiratory tract infection, arthralgia, nausea, urinary tract infection and diarrhea.
The panelists were concerned, however, that one of the Phase III trials failed to demonstrate a benefit of belimumab in black patients. African-American women are three times more likely to get lupus than other women and they are more likely to develop the disease at a younger age and have more severe symptoms.
The FDA is expected to issue a final decision on December 9th.
If approved, Benlysta would be dosed at 10 milligrams per kilogram at 2-week intervals for the first three doses, and then at 4-week intervals thereafter. The drug will also likely carry a warning label to state that the drug wasn’t tested in patients with the most severe forms of lupus or in certain populations, such as those with kidney disease.
According to the Lupus Foundation of America, about 1.5 million people are affected in the United States.