French drug major Sanofi's (Euronext: SAN) US biotech subsidiary Genzyme announced today positive top-line results from the TOPIC trial for Aubagio (teriflunomide). The trial was designed to assess whether early initiation of the drug in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome (CIS) can prevent or delay conversion to clinically definite multiple sclerosis (CDMS).
Clinically isolated syndrome (CIS) is defined as a first clinical attack with features suggestive of MS. It typically occurs in young adults and is often a prelude to CDMS. In the TOPIC trial, patients receiving Aubagio 14mg and 7mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo. Additional results, including key secondary and tertiary objectives, will be presented at a forthcoming scientific meeting.
Primary results were:
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