Rocky Mountain MS Center shares this Breaking News
The U.S. Food and Drug Administration has approved a new, once-daily, medication for the treatment of relapsing forms of multiple sclerosis. Aubagio (teriflunomide), made by Genzyme, a Sanofi company, is expected to be available for prescription in the US by October 1, 2012. This will be the second oral treatment available for MS. Aubagio has been investigated in three large clinical trials, and there are several more still underway.
In a phase III study named TEMSO, Aubagio reduced the average number of MS relapses and disease activity on MRI scans by as much as 31.5% over placebo. This study involved 796 people with relapsing forms of MS.
In a phase III TOWER study, 1,169 people with relapsing-remitting MS were randomly assigned to receive Aubagio 7 mg or 14 mg, once daily by mouth, or placebo for 48 weeks. The 14 mg dose reduced relapses by 36.3% versus placebo and a 7 mg dose reduced relapses by 22.3% versus placebo. In the 14 mg dose group, the time to disability progression was reduced by 31.5% and there was no significant reduction in the lower dose group.
In another study, called TENERE, Aubagio was compared with Rebif® (interferon beta-1a, EMD Serono and Pfizer) in relapsing MS, and did not reach its primary endpoint (the main question posed by the study) — the “risk of failure,” meaning the first occurrence of a relapse, or permanent discontinuation of the study treatment, whichever came first. There was no significant difference in the numbers of participants who experienced events defined as treatment failure among the Aubagio and Rebif groups. This suggests Aubagio and Rebif are similar in their effectiveness.
A range of 22-36 percent reduction in relapse rates is modest, but Aubagio has a good safety profile and with up to 10 years of continuous use in a Phase II extension, it has the longest clinical experience of any investigational oral MS therapy.
The most common side effects of Aubagio experienced by patients in clinical trials included diarrhea, abnormal liver tests, nausea, and hair loss, according to the FDA. Before people begin taking Aubagio, they should have their liver enzymes tested. This testing should continue monthly for the first six months and after the first six months, patients should be monitored for signs of liver damage.
“The true potential of this drug rests in its possible use as a combination therapy,” advises Dr. Timothy Vollmer, Medical Director of the Rocky Mountain MS Center and Professor at the University of Colorado School of Medicine. “Combination therapies ideally combine two moderately effective but safe therapies such that they can be highly effective while maintaining a good safety profile. The result is a more effective and safe treatment option for people with MS.”
Currently there is a study (The TERACLES trial) evaluating the effect of Aubagio taken in combination with interferons. This phase III study aims to recruit 1455 participants worldwide. The study will compare relapse rates while taking one of two doses of teriflunomide or placebo added on to existing beta interferon treatment over a treatment period of between 48 to 152 weeks.
The estimated completion date of this study is April 2014.
Reprinted with consent from…
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