An experimental lupus drug has just met another key goal in its journey
to becoming the first approved treatment for the disease in over 50
years. The target of the new drug, known as Benlysta, is to suppress
the response of the body’s immune system to lupus in an attempt to
control the actions of a protein that becomes overactive in lupus
patients.
Hopes were that the study data from a clinical program
called Bliss-76 would confirm the optimistic results of a prior
late-stage study. In actuality, the indications of the Bliss-76 data
were that a 10-milligram dose of Benlysta, accompanied by therapy with
steroids, resulted in improvement among 43 percent of lupus patients
taking a higher dose, as well as a 40.6 percent of those taking a lower
dose. This is compared to improvements observed in only 33.8 percent of
patients taking a placebo.
Makers of the drug, Human Genome
Sciences (HGS) based in Rockville, Maryland, and GlaxoSmithKline based
in the United Kingdom, now plan to seek the regulatory approval of the
U.S. Food and Drug Administration in the early months of 2010. If
approved, Benlysta could be available on the market by late next year.
In
a statement, HGS President and CEO H. Thomas Watkins said, “The
Bliss-76 results confirm our view that Benlysta has the potential to
become the first new approved drug in decades for people living with
systemic lupus.” He then added, “We take great pride in the innovation
and scientific rigor that has made it possible to bring Benlysta to
this point.”
The Bliss-76 study was the second of two late-stage
studies, and involved 865 patients who were treated and monitored over
a period of one year.
In October of this year, the first late-stage
study, called Bliss-52, involved over 800 patients in Asia, South
America and Eastern Europe, and has positive results in meeting several
key goals.
Lupus is an inflammatory, autoimmune condition, in
which the body’s defense system against pathogens attacks the body’s
own tissue causing health issues such as rashes, mouth sores,
arthritis, and kidney damage among other problems.
Because the illness
manifests itself differently in each patient, it is difficult to
develop effective treatments against the disease. According to Watkins,
“We’ve got a good chance to redefine the standard of care for patients
living with lupus.”
While one recent study estimated that
322,000 Americans most likely have the most common form of lupus known
as systemic lupus erythematosus, the Lupus Foundation of America
estimates that about 1.5 million Americans have some form of the
disease. According to Sandra C. Raymond, the organization's president
and chief executive, “Individuals with lupus and their families have
waited more than 50 years to hear that it is possible to develop
therapies that control the disease.” She went on to say, “We believe
that this is a significant first step in developing the full arsenal of
therapies and personalized treatment lupus requires.”
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