July 20, 2009
BENLYSTA™ Successful in First of Two Pivotal Clinical Trials
Today, Human
Genome Sciences (HGS) and GlaxoSmithKline (GSK) announced positive
results from a year-long clinical trial of BENLYSTA for treating lupus.
When the 52-week study concluded, the lupus patients who were treated
with BENLYSTA had improvement in overall disease activity without
clinically significant flare-ups in one or more isolated organs when
compared to patients who received the placebo (inactive agent). The
patients receiving BENLYSTA also were able to reduce their intake of
steroid medications. The study is the largest ever to be completed for
lupus and the first Phase III (late stage) trial of a new biologic
immune therapy for lupus to succeed in meeting its primary endpoint and
most of its secondary endpoints.
Sandra C.
Raymond, President and Chief Executive Officer of the Lupus Foundation
of America (LFA) issued the following statement.
"For people
with lupus and their loved ones, this is an historic day! With no new
drugs for more than 50 years, since the Eisenhower Administration, the
news today indicates that it is possible to develop new, safe, and
effective therapies for lupus. We are greatly encouraged by the
positive top-line data which shows that HGS’ 52-week BENLYSTA study met
its primary endpoint. These results provide hope that this complex
chronic autoimmune disease can be brought under control and that,
eventually, a cure can be found for the estimated 1.5 million Americans
and more than 5 million people worldwide living with lupus.
"We look
forward to hearing the results, this fall, of a longer-term Phase III
clinical study of BENLYSTA. The data from both studies will be
evaluated by the U.S. Food and Drug Administration (FDA). Should the
FDA ultimately approve BENLYSTA, it would become the first drug
successfully developed to specifically treat lupus since the disease
was discovered more than a century ago.
"Lupus is a
complex disease and not every therapy will be appropriate for all
patients. Each person with lupus is unique and it is likely that
successful management of lupus will require a number of therapies,
perhaps used in combination with each other. The LFA and its
Medical-Scientific Advisory Council urge the federal government and
industry to greatly step up their research efforts on lupus so that
physicians have a complete arsenal of therapies at their disposal to
provide the individualized treatment that lupus requires.
"We are
grateful to Human Genome Sciences and GlaxoSmithKline for their
pioneering efforts to develop a new, safe, effective and tolerable
treatment for lupus, to the physicians who have passionately committed
to researching this disease, to the companies who continue to invest in
finding new treatments, and to the thousands of people with lupus who
have volunteered and participated in clinical studies over the years so
discoveries such as this one could be possible.
"Meanwhile, the LFA will continue to implement its initiative entitled, A New 21st Century Approach to Lupus Healthcare,
to ensure the ongoing advancement of the science and medicine of lupus
to meet the multi-dimensional needs of people with lupus."
For more information, Click Here