Genzyme, a Sanofi company, has announced FDA approval of Aubagio (teriflunomide) as a 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 Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center, medical director Dr Aaron Miller said; "The FDA's approval of AUBAGIO, a new oral treatment option, is an encouraging advancement for the MS community and may be a valuable treatment for people living with this often debilitating disease."
The Aubagio label includes a boxed warning citing the risk of hepatotoxicity and teratogenicity (based on animal data).
The drug demonstrated similar adverse events when compared to placebo-treated patients in the MS clinical studies.
The most common adverse events associated with Aubagio in MS patients included increased ALT levels, alopecia, diarrhoea, influenza, nausea and paresthesia.
FDA Center for Drug Evaluation and Research Neurology Products Division director Russell Katz said; "In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo."
Image: Aubagio (teriflunomide) approved as as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Photo: Courtesy of Genzyme.