FDA approves label change for oral MS drug Aubagio
Posted: Mon Oct 20, 2014 11:56 pm
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..... Read More - http://www.ms-uk.org/aubagio
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..... Read More - http://www.ms-uk.org/aubagio