Will Pending FDA Decision OK First Lupus Drug in 52 Years?

After applauding an advisory panel’s strong recommendation in mid-November that the FDA approve marketing of the experimental lupus drug, Benlysta™ (belimumab), the lupus community now awaits the final FDA decision – scheduled for March 10.

On November 16, after reviewing the research and listening to the moving testimony of a dozen lupus patients and their families [see video excerpts below], the FDA’s Arthritis Advisory Committee voted overwhelmingly (13 to 2) to recommend the experimental drug Benlysta for approval as a treatment for the very serious, ill understood, and hard-to-treat autoimmune disease lupus.

Excerpts from the testimonies shared at FDA panel hearing.

Why the Wait?
Importantly, Benlysta research so far appears to indicate that for some patients it can support more improvement than ‘standard care’ alone, and/or reduce the need for other drugs with harmful side effects.

But the disease takes many forms, and Benlysta does not work for all patients. For example, reportedly it didn’t help African-Americans, who are three times as likely to develop lupus as Caucasians. (For information on the latest study, a large international, placebo-controlled trial, click HERE.)

Accordingly, the FDA wanted several months’ time before they make a decision – presumably to consider the data for insights on safety & efficacy, and how that might translate into guidelines for the drug’s use before making a decision. For example, reportedly they will be taking a careful look at how the drug might best be labeled – e.g., limitations on its prescription, such as patient types/circumstances not clearly represented in the studies.  

Advocates Applaud Benlysta as Step Forward
The Nov 16 Advisory Panel recommendation was “a great day for lupus” said Lupus Foundation of America President and CEO Sandra C. Raymond.

Acknowledging that Benlysta is a first step of sorts, she said:

“Lupus is unique from person to person. We need an arsenal of treatments, and I think now we now have the opportunity to get them. Finally. After 52 years. I say to the panel, congratulations, you did the right thing.

“I say to the company, you’re pioneers. It’s like carving that path moving to the West in the 1800’s. That’s what they’ve done in Lupus. They’ve carved a path and now it’s up to the rest of the companies to come through and improve upon the kinds of medications we have right now, and on Benlysta, so that we can better treat individuals with Lupus.”

For plain language information on recent research studies & findings, see the American Lupus Foundation’s “Research Summaries” page. Each research category lists summaries starting with the most recent. Summaries of Benlysta studies are included under “Lupus Treatments.”

And for the detail oriented, following is a video by researchers discussing the different Benlysta trials conducted to date and the difficulty of studying any treatment in a patient population with such widely varying manifestations and severity.


Sources: Lupus Foundation of America press release, Nov 16, 2010; LFA website and video statements; commentaries of various drug industry and market blogs following Benlysta's prospects.

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