FDA Approves 1st Oral Drug to Reduce MS
WEDNESDAY, Sept. 22 (HealthDay News) -- The U.S. Food and Drug
Administration on Wednesday approved the first oral drug to reduce
relapses of multiple sclerosis, the nervous system disorder that
has traditionally been treated with injectable drugs.
Gilenya (fingolimod) is designed to reduce relapses and delay
the progression of debilitating symptoms in patients with relapsing
forms of multiple sclerosis (MS). The drug, which works by altering
the immune system response, will be available in capsule form.
Research published in January in the
New England Journal of Medicine found that Gilenya reduced
relapse rates in people with relapsing-remitting multiple
sclerosis. However, as is often the case with immune-suppressing
medications, there were concerns about side effects, including an
increased risk of serious infections and, possibly, cancer.
"Oral drugs are what people with MS have been wishing for a long time. This is wonderful news for people with MS," Dr. John Richert, former executive vice president of research and clinical programs for the National Multiple Sclerosis Society, told HealthDay at the time the research was published. The drug
appears to be "quite effective," and at the moment, appears to have
a reasonable risk-benefit ratio. "However," he added, "it will be
very important for people with MS and their physicians to remain
vigilant and be on the lookout for side effects."
The January research was funded by the drug's manufacturer, the
Swiss pharmaceutical company Novartis.
Multiple sclerosis is a chronic, potentially disabling illness
that's believed to be an autoimmune disorder. In MS, the body's
natural defense system mistakenly attacks the fatty substance that
protects the nerves (myelin) in the brain and spinal cord. About
400,000 Americans have multiple sclerosis, which is characterized
by periods of well-being followed by periodic relapses, according
to the multiple sclerosis society.
Until now, the existing treatments for reducing relapses in
relapsing MS were all injectable medications, which Richert said is
sometimes a barrier for people to start early treatment. He said
that treatments may be more successful if they're started early in
the course of the disease, so he's hoping that having oral
medications will help people start treatment sooner.
The two Gilenya studies published in January were phase 3
studies. One study included more than 1,000 people with
relapsing-remitting MS. The study participants were randomly
selected to receive a daily dose of 0.5 milligrams (mg), 1.25 mg or
Annual relapse rates were less than 1 percent each year, and 54
percent less for the lower dose of Gilenya and 60 percent for the
higher dose. The study also found slower disease activity and
In the second study, 1,153 people with relapsing-remitting MS
were randomly assigned to receive a daily dose of 0.5 mg or 1.25 mg
of Gilenya or a weekly dose of 30 micrograms of interferon beta-1a
(Avonex) for one year. The annual relapse rate on either drug was
less than 1 percent in this study as well. However, the people on
Gilenya had up to a 52 percent lower relapse rate. This study found
no significant differences in disease progression between the two
Both studies found that the lower dose of the drug was better
tolerated. A small number of serious infections occurred, including
two deaths from herpes infections in these studies. And, there
appeared to be a higher incidence of cancer in people taking
Novartis said Wednesday that the FDA approved a 0.5-milligram
daily dose of Gilenya.
To learn more, visit the
National Multiple Sclerosis Society.
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