FDA Oks Label Change for MS drug

The US Food and Drug Administration (FDA) approved Genzyme’s application to include new information about its multiple sclerosis drug teriflunomide (Aubagio) on its label. The new labeling content is efficacy and safety data from two Phase III trials of the drug.

One trial, a study known as TOPIC is described in the Sept., 2014 issue of The Lancet Neurology. In it Aaron Miller, MD and colleagues report that in 618 relapsing-remitting multiple sclerosis patients assigned to the drug or placebo those who got the drug had a significantly reduced risk of relapse. The patients got a single daily oral dose of either 14 mg or 7 mg (or placebo) for up to 108 weeks.

The study was conducted from Feb 13, 2008 to Aug. 22, 2012 at 112 medical centers in 20 countries.

The patients getting teriflunomide did better than placebo at either dosage at preventing relapses without serious side effects.

Miller is medical director of The Corinne Goldsmith Dickinson Center for Multiple Sclerosis at the Mount Sinai Hospital in New York, NY.

In a statement from Genzyme, Miller said “Aubagio is the only oral multiple sclerosis treatment that has demonstrated a positive effect on disability progression in two Phase III clinical studies and is the only oral therapy with supporting published efficacy data on the treatment of patients who have experience a first clinical attack.”

The drug was originally approved for US use in 2012.

Pooled data from TOPIC and two other studies involving 2,000 subjects found that though patients experienced adverse events including decreased white blood cell count, peripheral neuropathy, skin reactions and increased blood pressure, the rate at which the subjects reported these events was about the same as in subjects who were taking placebos.

The drug is an immunomodulator with anti-inflammatory properties. It is believed to reduce the number of activated lymphocytes in the central nervous system.

It is contraindicated for patients with severe liver problems and in women who are pregnant or may become pregnant since animal studies indicate teratogenicity.