The FDA has approved Genzyme, a Sanofi company, Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for relapsing forms of multiple sclerosis (MS).
Aubagio, an immunomodulator with anti-inflammatory properties, has shown significant efficacy across key measures of MS disease activity, such as reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.
Genzyme president and CEO David Meeker said, "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."
The approval was based on efficacy data from the TEriflunomide Multiple Sclerosis Oral trial in which Aubagio 14mg significantly reduced the annualised relapse rate (p=0.0005) and the time to disability progression (p=0.0279) at two years versus placebo in patients with relapsing forms of multiple sclerosis.
Aubagio 7 mg was shown to significantly reduce the annualised relapse rate (p=0.0002) in the trial.
The Aubagio label includes a boxed warning citing the risk of hepatotoxicity and, teratogenicity (based on animal data). The drug demonstrated similar advance events when compared to placebo-treated patients in the MS clinical studies.