Benlysta, first new lupus drug in more than half a century, wins FDA approval

WASHINGTON -- The Food and Drug Administration on Wednesday approved Benlysta as the first new drug treatment for lupus in 56 years, offering possible relief from painful symptoms to victims of the sometimes-fatal autoimmune disease.

Government approval also sets the stage for likely blockbuster sales for the drug’s developer, Human Genome Sciences Inc. The decision was widely expected after an FDA advisory panel voted 13-2 in November to recommend approval of the drug.

But the approval has an outsized importance too because it comes after years of failures to develop treatments for lupus, said Sandra Raymond, president of Lupus Foundation of America.


“It’s an historic day. It really does open a door,” Raymond said. “Not that Benlysta is a miracle drug. It’s not. I think the lupus community is sanguine about that. But they know that there are other companies coming behind” Human Genome.

Benlysta is the first FDA-approved drug for Human Genome, an 18-year-old biotech firm in Rockville, Md. It has potential global sales of $5 billion, with almost $3 billion of that coming in the U.S., according to Avik Roy, who follows the company for Monness, Crespi, Hardt & Co.

Human Genome is slated to split the profit with its marketing partner, GlaxoSmithKline.