benlysta news — FDA panel backs the drug

I’m late getting to this, but it was my kiddo’s bday and I haven’t really been online today…

Here’s some info and then the link::

The drug, Benlysta, acts as a kind of biological volume control
Lupus drug Benlysta shows promise, company says
An experimental lupus drug that produced favorable results in a company-backed study has prompted its makers on Monday to tout the drug as potentially the first new drug for lupus in half a century.
The drug, Benlysta, acts as a kind of biological volume control, dialing down the intensity of the immune response that attacks lupus patients’ tissues, often wreaking havoc in vital organs.

All 865 patients in the trial were given standard therapy for lupus, with steroids as a mainstay of treatment. Researchers found that 52% of patients on a low dose of Benlysta and 58% of those taking a high dose of the drug, along with standard therapy, experienced a significant improvement in their disease, compared with just 43% of those taking standard therapy and a placebo.

More Benlysta patients were able to reduce their steroid dose, and with it the bloating and other side effects of steroid use, company officials said.

“It’s outstanding news,” says David Stump of Human Genome Sciences Inc., which developed the drug with GlaxoSmithKline. “All of the investigators we’ve shown (these results to) are just thrilled. They haven’t had a good clinical trials result in years. Lupus patients should have some hope, too.”

FIND MORE STORIES IN: GlaxoSmithKline | Human Genome Sciences
The study was designed to determine whether patients taking the drug achieved a favorable response on three stringent measures of lupus severity. Lupus is a complex disease that waxes and wanes, with flare-ups caused by antibodies that attack the brain and other organs.

About 1.5 million people in the USA have lupus.

Benlysta fights these naturally occurring antibodies with man-made antibodies. Because the digestive tract would break Benlysta down, the drug must be taken intravenously in one-hour outpatient sessions, once a month.

Half of the patients in an earlier trial have continued taking the drug four years after they began, Stump says, even though the drug has proven to be safe and well tolerated.

Joan Merrill, a lupus expert at the Oklahoma Medical Research Foundation, says that’s not a low number, considering the volatility of lupus. Rather, she says, the fact that half of the patients who started taking the drug continued is a sign they’re benefiting from treatment.

“If they didn’t think they were getting something out of this, they wouldn’t come,” says Merrill, who was not involved in the study reported today, but was involved in the earlier study and other studies on behalf of the drug[‘]s makers.

Stump and other company officials declined to release drop-out rates for the new study, but they say they those who dropped out were accounted for in the study’s results, which were still positive.

The company plans to release the results at a scientific meeting later this year, Stump says. The results will be released to investors and analysts in a conference call Monday.


*One more thing, from the LFA website (

How does BENLYSTA work?
BENLYSTA is a human monoclonal antibody that specifically recognizes and blocks the biological activity of B-lymphocyte stimulator, or BLyS® (pronounced bliss), a naturally occurring protein which was discovered by scientists at Human Genome Sciences (HGS). Elevated levels of BLyS prolong the survival of B cells which can contribute to the production of autoantibodies — antibodies that target the body’s own tissues. Previous studies have shown that BENLYSTA can reduce autoantibody levels and help control autoimmune disease activity.

NY Times Article

Christine Writes and Weighs In!


About Amy Cate

I have lupus. I'm doing my damndest to advocate and spread awareness. This is just one of the ways I'm involved =D
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