Lupus Drug: FDA approves Benlysta to treat patients who suffer from the disease.
Lupus Drug: FDA endorses Benlysta. The FDA voted 13-2 to recommend approval of the first new drug for lupus. Benlysta was developed to treat patients who suffer from the autoimmune disease.
Benlysta is made by Human Genome Sciences and GlaxoSmithKline. Lupus is an autoimmune disease in which the body produces antibodies that attack and destroy healthy tissue. This can damage joints, skin, blood vessels and organs.
The drug works by inhibiting the production of these antibodies. While the FDA is not bound by its advisory committees’ recommendations, it usually follows them. In a report submitted to the advisory committee before the vote, the Food and Drug Administration had expressed some concerns about the efficacy and safety of the drug.
But other experts expressed optimism about the drug’s worth.
“I really do think the drug is efficacious,” Sandra C. Raymond, president & CEO of the Lupus Foundation of America, said in a statement. “What I’m hearing in terms of efficacy is pretty strong.” In a statement commenting on the panel’s vote, Margaret Dowd, president and CEO of the Lupus Research Institute, said that “we couldn’t be more pleased. It’s a historic day for the lupus community.”