June 26, 2014

FDA approves second oral medication for treatment of relapsing forms of MS

The U.S. Food and Drug Administration has approved teriflunomide once-daily pills (Aubagio® Genzyme, a Sanofi company) to treat relapsing forms of MS. Aubagio (pronounced oh-BAH-gee-oh) is a novel oral compound that inhibits the function of specific immune cells that have been implicated in MS. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes), reducing the proliferation of T and B immune cells active in MS and also inhibiting the production of immune messenger chemicals by T cells. It is not thought to affect resting immune cells that are not in an activated state. Two doses (7mg and 14 mg) have been approved in the United States.

The Studies: Three large clinical trials of Aubagio have been completed, and at least two more are ongoing. In the phase III TEMSO study, Aubagio reduced the average number of MS relapses and disease activity on MRI scans significantly more than inactive placebo in 796 people with relapsing forms of MS. In a recently completed phase III TOWER study involving 1,169 people with relapsing-remitting MS, oral Aubagio reduced relapses compared with placebo over at least 48 weeks, according to a company press release. Of two different doses tested during the TOWER trial (7 mg and 14 mg), the higher dose also slowed progression of disability.

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.

In trials to date, Aubagio was generally safe and well tolerated. The most common side effects experienced by participants in clinical trials include diarrhea, abnormal liver tests, nausea, flu, and hair thinning. The prescribing information includes a boxed warning related to the potential for liver damage in persons taking Aubagio.

Canada played an instrumental role in the development of teriflunomide, specifically in leading Phases II and III of the TEMSO study with significant involvement of researchers, clinicians and patients from the Canadian Network of MS Clinics. The MS Society of Canada will provide updates on continued trials and/or other information related to teriflunomide in Canada.

With information from the National MS Society (USA) www.nmss.org