The US
Food and Drug
Administration on
Wednesday approved
the first new drug to
treat lupus in over 50
years,
Known as Benlysta,
the injectable drug is
designed to relieve
flare-ups and pain
caused by lupus, a
little-understood and
potentially fatal
ailment in which the
body attacks its own
tissue and organs.
Biotech drugmaker
Human Genome
Sciences Inc. spent 15
years developing
Benlysta and will co-
market it with
GlaxoSmithKline PLC.
The companies
estimate there are at
least 200,000 lupus
patients in the U.S.
who could benefit
from the drug.
But experts stress that
Benlysta is not a
miracle drug: It only
worked in 35 percent
of North American
patients tested and
was not effective for
patients with the
deadliest form of the
disease. Additionally, it
did not show positive
results in African
Americans, who are
disproportionately
affected by lupus.
FDA said in its news
release it would
require the drug
developers to conduct
another study
exclusively in African
Americans.
Dr. Betty Diamond,
who has studied lupus
for 30 years, said
Benlysta should
provide
encouragement to
researchers and drug
developers.
"It will send out the
message that it's
possible to conduct a
successful clinical trial
in lupus and that's
tremendously
important to keep the
pharmaceutical
industry interested in
this disease," said
Diamond, a researcher
at the Feinstein
Institute in New York.
Janice Fitzgibbon of
McLean, Virginia has
been taking Benlysta
for two years as part
of the drug's clinical
trial program.
"It's given me my life
back," she said, after
being so crushed by
pain that she couldn't
take her dog for a
walk or drive her
children to school.
"It's a bittersweet
thing for me because I
have friends with
lupus for whom this
drug won't work," said
Fitzgibbon, who is 54.
"There's no one-size-
fits-all for lupus and
I'm just extremely
fortunate that my
lupus is mild and is
helped by Benlysta."
FDA approved the
drug for systemic
lupus erythematosus,
the most common
form of the disease.
Ten-year survival for
patients diagnosed
with the illness is more
than 85 percent,
according to the
National Institutes of
Health.
Lupus patients have
long struggled to draw
attention to their
disease, which affects
women nine times
more than men.
African Americans are
three times more likely
to have the disease.
"I don't think there's a
conspiracy here, but it
just hasn't gotten a lot
of funding and it
hasn't gotten a lot of
attention from the
media," said Dr. Abby
Abelson, chair of the
Department of
Rheumatologic and
Immunologic Disease
at the Cleveland
Clinic.
Lupus causes fibrous
tissue and
inflammation of
internal organs, skin
rashes and joint pain.
Most of Benlysta's
benefit came from
relieving muscle
inflammation versus
organ problems, as
measured on a
comprehensive
checklist of lupus
symptoms.
The disease occurs
when the body's
protector cells, known
as antibodies, stop
differentiating
between foreign
invaders, like bacteria,
and healthy cells. The
cause of this
malfunction is not
understood.
Currently most
patients treat their
disease with a variety
of drugs that help
ease inflammation,
including painkillers,
steroids and
antimalarial drugs —
which were first
approved for lupus in
the 1955. Many
patients say the side
effects of those
treatments are nearly
as uncomfortable as
the disease itself.
Steroids can cause
bone fractures, weight
gain and infection.
Wednesday's approval
completes a
remarkable
turnaround for
Rockville, Md.,-based
Human Genome
Sciences which has
been developing
Benlysta since 1996
and has no other
products on the
market. The company
originally tested
Benlysta, known
generically as
belimumab, as a
treatment for
rheumatoid arthritis.
When a mid-stage trial
in lupus patients failed
to meet researchers'
goals in 2006, many
analysts wrote the
drug off and
downgraded the
company's stock. But
when scientists
reanalyzed the data
they found that the
drug helped block the
antibodies that cause
lupus symptoms in a
subset of patients.
Analysts estimate the
drug could reach
annual sales exceeding
$3 billion within five
years.
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