FDA Advisory Committee recommends approval of the first new lupus treatment in more than 50 years

November 16, 2010

A Public Hearing Convenes to Weigh the Risks and Benefits of Belimumab 

FDA Advisory Committee recommends approval of the first new lupus treatment in more than 50 years

A landmark meeting of the Arthritis Advisory Committee took place today outside of Washington, DC to weigh the risks and benefits of belimumab (proposed trade name BENLYSTA™) and provide guidance to the Food and Drug Administration (FDA) in making its decision about approving the lupus drug for patient use.  After a day of scientific presentations, public hearings and detailed discussions, the Committee deliberated in an open forum, and voiced its opinion that it recommends (by a vote of 13 to 2) that the FDA approve belimumab for the proposed indication of reducing disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE).  If approved, belimumab, brought to you by Human Genome Sciences (HGS) and its partner GlaxoSmithKline (GSK), will be the first new lupus drug in more than 50 years. 

“Lupus patients and their families, along with lupus investigators who have worked long and hard to understand this most complex disease, are encouraged by important progress in lupus drug development,” says Dr. Peggy Crow, Chair of the Scientific Advisory Board of the Alliance for Lupus Research (ALR).  “Today’s decision represents a significant milestone in lupus research.  We are hopeful that the decision made today on behalf of the Arthritis Advisory Committee will not only support the FDA approval of belimumab, which will be the first new option for people affected by lupus in more than five decades, but will also provide guidance and insights to help further other research into additional new therapeutic options for people with lupus.”

The Alliance for Lupus Research (ALR) Onsite to Voice Support

The ALR is proud to have had the opportunity to be among the hundreds attending the Advisory Committee meeting, and is pleased to bring you highlights from the day.

A look at the day-long meeting:

• Presentations from the drug’s maker HGS and lupus researchers spoke about the great unmet need in lupus treatment and provided an overview of the safety and efficacy of belimumab as demonstrated in its clinical trials.  More information about the drug’s development program can be found here.

• Members from the FDA were on-site to discuss some important efficacy, safety and statistical considerations in evaluating belimumab for potential approval and to carefully weigh both the benefits and risks as demonstrated in the drug’s clinical trials. 

• During the open public hearing that was part of the day’s meeting, people touched by lupus nationwide told their personal stories about the devastating impact of lupus on their lives and the significance of a new option for the millions touched by the disease.  Unlike many countries, in the United States, the public has an opportunity to have input into the process of the review of new drug therapies.  The ALR’s volunteer representatives Brenda Blackmon and Angie Hudnell presented at the meeting today and made pleas to the Committee for a new treatment option for those living with lupus.

• The Advisory Committee deliberated by discussing all of the day’s presentations, and voted 13 to 2 in favor of the FDA approving belimumab for use in lupus patients.

“There are so many people who can’t be here today who have died waiting on a drug to treat lupus that can actually make a difference,” explains Brenda Blackmon, volunteer representative for the ALR.  “For those families who still live with lupus every day, I am proud to have made a difference today by sharing my daughter’s story about being diagnosed with lupus in college and appealing to the Arthritis Advisory Committee to recommend approval for the first lupus drug in 50 years.”

Blackmon adds, “every time I think about it, I cry about our family’s experience with lupus.  But for so many people who are touched by lupus, the tears won’t stop until a drug is found.  For me, being here today is more than a 3 minute speech about my daughter’s story, it is an opportunity to help make a difference in the lives of people around the world touched by lupus.”

What’s Next for Belimumab on the Path to Potential FDA Approval

While the FDA is not required to follow the Committee’s recommendation, it typically does.  The FDA is expected to make its decision about approving belimumab for patient use by the end of the year.  

The ALR will continue to report on new research and milestones surrounding belimumab, as well as other therapies in development for treating lupus.

Advancing Lupus Research, Providing Hope For a Cure

Over the past 10 years, the Alliance for Lupus Research (ALR) has advanced pioneering lupus investigations and has achieved great progress in lupus research, including supporting some of the important basic and translational research on the molecule targeted by belimumab, BLyS, also called B-cell activating factor (BAFF).  The ALR has funded more than five million dollars in B-cell research. 

To help us continue funding important B-cell and other research into potential new treatment options -- and one day a cure -- please text LUPUS to 85944 to make a $10 donation to the ALR today!  A one-time donation of $10 will be billed to your mobile phone bill.  Messaging & data rates may apply.  Donations are collected for the Alliance for Lupus Research by mobilecause.com.  Reply STOP to 85944 to stop.  Reply HELP to 85944 for help.  For terms, see www.igfn.org/t. 

The ALR is committed to supporting important research that will one day prevent, treat and cure lupus.  The ALR is the world’s largest charitable funder of lupus research.  One hundred percent of all donations to the organization support innovative medical research programs focused on preventing, treating and curing systemic lupus erythematosus or lupus, as the Board of Directors funds all administrative and fundraising expenses.  More information about lupus and the ALR is available at www.lupusresearch.org.