Benlysta: Human Genome Sciences' New Lupus Drug Approved

Benlysta Approved by FDA: Will It Work For Lady Gaga?

Benlysta, a lupus treatment drug, was approved by the US Food and Drug Administration (FDA), making it the first new lupus drug in over 50 years. Human Genome Sciences, Inc (HGSI), the company behind Benlysta, faces a new challenge, though: how to sell the drug.

Lupus has no cure: Benlysta, like its predecessors, only manages the disease. Despite what what we see on House, lupus affects roughly 1.5 million Americans, mostly women. In fact, Lady Gaga tested borderline positive for lupus; it runs in her family. Will Lady Gaga benefit from Benlysta? Maybe. She'd at least be part of the demographic that can afford the intravenous drug, which costs around $35,000 a year. Insurance companies aren't ready to cover Benlysta yet, and it is only recommended when other treatments have failed.

So we're looking at a relatively small pool of potential patients at first. Its benefits have been described as mild, and must be taken in conjunction with other treatments. In trials, Benlyn had beneficial effects on 43% of patients, as opposed to a placebo, which had a 34% success rate.

Meanwhile, Human Genome Sciences must do additional trials with African-American patients, as the drugmaker doesn't have enough data to gauge Benlysta's effectiveness in that demographic .

What is Lupus?

Lupus is an autoimmune disorder which causes the body to attack itself. It causes arthritis, organ failure, hair loss, fatigue, and rashes. Lupus can be fatal in some cases. Lupus info via the Mayo Clinic: remember that the web is no substitute for a real-life doctor.