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Results Published from Aubagio Clinical Trials: FDA OKs Addition of New Results to Prescribing Information

November 11, 2014

The results of two Phase 3 clinical trials of Aubagio® (teriflunomide, Genzyme/Sanofi-Aventis) for relapsing forms of multiple sclerosis have been published, and these results have been approved by the U.S. Food and Drug Administration for inclusion in the prescribing information for Aubagio. New information includes the ability of Aubagio to reduce the risk of relapse in people who have experienced a first clinical event suggestive of MS (clinically isolated syndrome) – this is the first such report in an oral MS treatment.

Background: Aubagio was approved by the FDA in September 2012 for people with relapsing forms of multiple sclerosis. Aubagio is an oral compound that inhibits the rapid proliferation of cells, including immune cells that have been implicated in MS.

TOPIC Study: Investigators worldwide recruited 618 people 18-55 years of age with clinically isolated syndrome (CIS, a first clinical episode suggestive of MS) who showed two or more areas of damage on MRI scans and had experienced their neurological symptoms within 90 days prior to entering the study. Participants were randomly assigned to receive 7 mg teriflunomide, 14 mg teriflunomide, or placebo once daily for 108 weeks. The primary outcome measured was time to relapse.  A secondary endpoint was time to relapse or the occurrence of new tissue damage on MRI scans, whichever occurred first.

The risk of relapse was reduced by 42.6% among those taking 14 mg of Aubagio, and by 37.2% among those taking 7 mg Aubagio, compared to those taking placebo. For the secondary endpoint, the risk of relapse or occurrence of new tissue damage was reduced by 34.9% in the 14-mg group and 31.4 % in the 7-mg group compared with the placebo group.

The most common adverse events reported in the Aubagio groups were liver enzyme elevations, hair thinning, diarrhea, upper respiratory infection, and paresthesia (e.g., burning sensations, pins and needles, stabbing pains). There was one death due to suicide in the placebo arm. (Lancet Neurology 2014;13:977-86)

TOWER Study: Investigators worldwide recruited 1,169 people with relapsing forms of MS, and randomly assigned them to receive teriflunomide 7 mg or 14 mg, once daily by mouth, or placebo for 48 weeks. The primary endpoint was whether the study drug reduced the average number of relapses per year significantly more than placebo. Secondary endpoints included the time to disability progression confirmed for at least 12 weeks.

Teriflunomide 14 mg reduced relapses by 36.3% versus placebo and 7 mg reduced relapses by 22.3% versus placebo. In the 14 mg-group, the risk of sustained disability progression was reduced by 31.5%; the lower dose did not significantly reduce progression.

Three deaths occurred in the teriflunomide groups – from sepsis, suicide, and motor vehicle accident. Participants in the teriflunomide groups experienced more liver enzyme elevation, headache, and hair thinning. (Lancet Neurology 2014;13:247-56)

Please note: Aubagio is Pregnancy Category X, as designated by the FDA, meaning that it may cause major birth defects if used during pregnancy. Aubagio is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception.

Read more about Aubagio.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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