FDA approves Benlysta to treat lupus

For Immediate Release: March 9, 2011 Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov; Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

Prior to Benlysta, FDA last approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

“Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. The studies diagnosed patients with active lupus and randomized them to receive Benlysta plus standard therapy, or an inactive infused solution (placebo) plus standard therapy. The studies excluded patients who had received prior B-cell targeted therapy or intravenous cyclophosphamide, and those who had active lupus involving the kidneys or central nervous system.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. To address this concern, the sponsor has agreed to conduct an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.

Those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with Benlysta.

The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Human Genome Sciences Inc., based in Rockville, Md., developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.

This drug may help selected lupus sufferers but it will not be much help to most sufferers. I congratulate the individuals who developed and brought this drug to market. Lupus is a difficult disease that has defied development of new treatments. Hopefully, this drug is just the beginning of new drugs and treatments.

Too expensive for me! I am the rare male victim and fortunately, its in remission. But I notice the side effects: tiredness, periodic leg muscle spasms, etc. No one likes living with an autoimmune condition. Unlike AIDs, its not necessarily fatal.

It is targeted primarily at SLE, true, and not even all of those patients will benefit. But from what I’ve seen of long-term continuation studies, for the patients in whom it works, it WORKS, reducing flare activity pretty close to zero.

There are also other auto-immune indications that this could potentially be used for; studies for those indications are either underway or going to launch soon. It’ll be a lot easier to get approvals for other indications than it was to get original approval, and I imagine there’ll be off-label use as well.

You may want to check it out anyway, that price is what they’re expecting to get from insurance companies and medicare/medicaid. (And they’ve been talking to insurers for a while now to get a good feel on what they’re willing to pay.) I believe I’ve seen something about assistance programs for those paying out-of-pocket.

Though, if you’re in remission, it may or may not be worth the risk and hassle of monthly infusions even if cost wasn’t an issue.

Your words are encouraging for my daughter. She was diagnosed 6 months ago at age 11. Overall her symptoms are mild but she has still missed lots of school this year over mysterious ailments.

I am not sure about your meaning of “other auto-immune” indicators. Are there new drugs being developed that build on this drug?

Belumilab (Benlysta) was originally developed to treat rheumatoid arthritis -- SLE lupus was a similar indication, and proved far easier to get approval via an FDA fast-track.

Basically, there are a whole class of autoimmune disorders that are linked with excessive B-cell production. Belumilab should be able to help with many of them, as it is a B-cell inhibitor.

From Human Genome Science's web page on Benlysta:

HGS and GSK are also examining a range of potential additional indications for BENLYSTA that might be explored in Phase 2 clinical trials, including vasculitis and post-renal transplant. In addition, a number of small proof-of-concept studies are already ongoing or imminent in Sjögren’s syndrome, Waldenstrom’s disease, pre-transplant and idiopathic thrombocytopenic purpura (ITP).

Not mentioned there, but I'm sure still in the works, is probably RA as well. I've also heard conjecture that some forms of Chron's might be treatable as well, but I can't recall how well founded that was.

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