By John Gever, Senior Editor, MedPage Today
Published: August 02, 2011
Published: August 02, 2011
The oral multiple sclerosis drug fingolimod (Gilenya) reduces T1 gadolinium-enhancing lesions on MRI scans, according to new label language cleared by the FDA.
Previously the drug was approved to reduce the frequency of disease flares in relapsing forms of MS.
Safety information in fingolimod’s label has also been revised to correct the time frame in which liver enzyme levels are most often elevated — usually within six to nine months after treatment begins, according to the drug’s manufacturer, Novartis.
The drug, which was approved last year, initially had label language indicating that liver transaminase elevations were most likely to be seen in the first three to four months.
Other postmarketing safety data on fingolimod have been consistent with the current label, Novartis said.
To support the new efficacy claim, Novartis submitted findings from two previously reported phase III clinical trials — the one-year TRANSFORMS study and the two-year FREEDOMS study.
In the active-controlled TRANSFORMS trial, mean T1 gadolinium-enhancing lesion counts were 0.2 after 12 months in fingolimod-treated patients, compared with 0.5 among patients receiving interferon-beta-1a (P<0.001).
Mean lesion counts at two years in the placebo-controlled FREEDOMS study were 0.2 with fingolimod versus 1.1 in the placebo group (P<0.001).
Fingolimod, a sphingosine-1-phosphate receptor modulator, is believed to work by keeping activated T cells from leaving the lymph nodes, thereby inhibiting the autoimmune attack on nerve fibers
My thanks to Cherie C. Binns RN BS MSCN for providing the information found above.
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