THURSDAY, June 10 (HealthDay News) -- An expert advisory panel
of the U.S. Food and Drug Administration on Thursday recommended
that the agency approve an oral drug, Gilenia, as a first-line
treatment for multiple sclerosis (MS).
Gilenia appears to be both safe and effective, the panel
confirmed in two separate votes.
Approval would mark a major shift in MS therapy since other
drugs for the neurodegenerative illness require frequent injections
or intravenous infusions.
"This is revolutionary," said Dr. Janice Maldonado, an assistant professor of neurology at the University of Miami Miller School of Medicine. "It's a marvelous achievement of being the first oral drug out for relapsing multiple sclerosis."
Maldonado, who has participated in trials with the drug, said
the results have been very encouraging. "All of our patients have
done well and have not had any problems, so it's quite promising,"
Patricia O'Looney, vice president of biomedical research at the
National Multiple Sclerosis Society, went even further, saying that
"this is a historic day. The panel recommended the approval of
Gilenia as a first-line option for people with MS."
As an oral drug, it opens the door to more MS sufferers
accepting treatment, she explained. "Those people who have not been
on therapy, for a variety of reasons, because they did not like the
injections, didn't like the infusions or they are not on therapy
because they didn't respond to the other drugs -- this is another
In its first vote of the day, according to the
Associated Press, the FDA panel voted 25-0 that the drug was effective in reducing relapses of multiple sclerosis, which causes a host of movement and cognitive problems.
But because side effects of the drug are a concern, the panel
voted that Novartis, the maker of Gilenia, conduct tests to see if
the drug is effective at lower doses, the
AP reported. However, the panel said that these tests could
be conducted after the drug reaches the market. Requiring such a
study before approval could have kept the drug off the market for
Currently, the FDA is reviewing the drug as a priority, which is
reserved for groundbreaking therapies. A decision is expected by
late September, according to the
A study of 1,200 patients conducted by Novartis showed about a
30 percent reduction in the relapse rate among patients taking
Gilenia, compared to older drugs, such as Bayer's Betaseron and
Biogen Idec's Avonex, the news service said.
However, the agency is concerned about serious side effects that
occurred in about 8.5 percent of patients taking Gilenia, compared
with 5.8 percent of patients taking older MS drugs, the
AP reported. Those side effects can include heart and lung
problems, and eye disorders.
Although the FDA is not required to follow its advisory panels'
recommendations, it usually does.
Around the world, about 2.5 million people suffer from MS, which
can cause muscle tremors, paralysis and problems with speech,
memory and concentration. In the most common form of the nervous
system disease, patients experience periods with no symptoms
followed by periodic relapses.
MS damages the myelin sheath, the material that surrounds and
protects nerve cells. This damage slows down or blocks messages
between the brain and the body, according to the U.S. National
Institutes of Health.
For more on MS, visit the
National Multiple Sclerosis Society.