Good News for Oral MS Drug Fingolimod
70% of Multiple Sclerosis Patients Are Relapse-Free After 3 Years on Fingolimod
April 16, 2008 -- Seventy percent of multiple sclerosis patients
taking the experimental drug FTY720 -- fingolimod -- were relapse free after
three years of daily treatment.
The finding comes from an extended phase II clinical trial in which all
patients receive the immunity-suppressing drug. Researchers Giancarlo Comi, MD,
of San Raffaele Hospital in Milan, Italy, reported the findings at this
week's meeting of the American Academy of Neurology in Chicago.
"The first-line treatments for MS ... reduce the relapse rate by only
about 30%, so this is a significant development for people with MS," Comi
says in a news release.
All current MS drugs must be administered by injection or infusion --
a huge disadvantage for patients, says neurologist Orly Avitzur, MD, medical
advisor for Consumer Reports. Avitzur was not involved in the fingolimod
"This drug is completely different from any other on the market for
MS," Avitzur tells WebMD. "It is the first oral MS drug to get this
far, and if it is successful in large-scale clinical trials, it will make a
huge difference in quality of life for MS patients."
In the phase II study, 173 patients with the relapsing form of MS (a type of
MS that repeatedly relapses and has periods of recovery in between) received
fingolimod for three years. More than 67% of the patients were free of relapses
after three years, with an annual relapse rate of 0.2%, says Shreeram Aradhye,
MD, vice president and senior global medical program director for Novartis, the
company developing fingolimod.
"When you look at all the biologic treatments [medications that target
the immune system to reduce the frequency and severity of attacks and reduce
lesions within the brain] for MS, this 0.2% annualized relapse rate seems to be
a new benchmark," Aradhye tells WebMD. "This was complemented by the
encouraging observation that 89% of patients at year three have no evidence of
inflammation in MRI brain scans [a sign of MS
Fingolimod Safety Good So Far, but Not Assured
So far, the most common side effects of fingolimod have been head colds, headache, and fatigue. But there have also
been a few cases of skin cancer, which has also been
reported in patients taking Tysabri, an approved MS drug.
Like Tysabri, fingolimod suppresses the autoimmune responses thought to
cause MS. In MS, haywire T lymphocytes -- the cellular generals of the immune
system -- order attacks on the myelin sheaths that surround and protect the
Tysabri is an engineered antibody that inactivates T cells. Fingolimod is a
molecule that deprives T cells of the signal they need to leave lymph nodes,
effectively stranding them outside the brain. It was originally designed to
help prevent organ rejection in transplant patients, but that didn't work out
very well, Aradhye says.