FDA Approves Fingolimod Update in Prescribing Information

Emma Hitt, PhD

August 02, 2011

August 2, 2011 — The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application for the oral multiple sclerosis (MS) drug fingolimod (Gilenya, Novartis); the prescribing information will now include data on T1 gadolinium-enhancing magnetic resonance imaging (MRI).

The supplemental New Drug Application approval means that the Clinical Studies section 14 of the fingolimod prescribing information will be updated to include T1 MRI findings from the 12-month TRANSFORMS and 24-month FREEDOMS studies. Both trials were submitted to the FDA to support the approval of fingolimod.

The data indicate that at 12 months, the mean number of gadolinium-enhancing T1 lesions was significantly lower for patients treated with fingolimod (0.5 mg) than for patients taking intramuscular interferon β-1a: 0.2 vs. 0.5, respectively (P < .001). The effect of fingolimod (0.5 mg) vs placebo at 24 months was also significantly different: 0.2 vs. 1.1 (P < .001).

"Neurologists commonly use gadolinium contrast MRI activity to assess for active inflammation in people living with MS," stated Barry Singer, MD, director of the MS Center for Innovations in Care at Missouri Baptist Medical Center in a company written release. "These data show that treatment with Gilenya helped to significantly reduce contrast MRI activity in people with relapsing-remitting MS."

In May 2011, the prescribing information Section 5.5 for fingolimod was also updated to define the period of time in which liver transaminase elevations occurred. Most elevations occur within 6 to 9 months after initiation of fingolimod treatment, as opposed to the 3 to 4 months listed in the original prescribing information.

Fingolimod is approved to treat relapsing forms of MS in adults. It can decrease the number of MS relapses and is the first oral medication for this indication. Adverse events associated with fingolimod include slow heart rate, increased risk for serious infections, macular edema, breathing problems, liver problems, and increases in blood pressure.

According to the manufacturer, more than 11,000 people in United States have been prescribed fingolimod since FDA approval in September 2010, and it is now approved in more than 40 countries.

Topline results from the BRAVO trial, a phase 3 investigation of another still-investigational oral agent, laquinimod, showed that trial missed its primary endpoint. The results were released August 1.


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