Genzyme, a Sanofi company (SNY, SNYNF.PK), announced positive top-line results from the TOPIC trial for AUBAGIO or teriflunomide. The company stated that the trial was designed to assess whether early initiation of Aubagio (teriflunomide) in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome or CIS can prevent or delay conversion to clinically definite multiple sclerosis or CDMS.
Clinically isolated syndrome 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 14 mg and 7 mg were significantly less likely to develop CDMS, defined as occurrence of a second clinical attack, the primary endpoint, as compared to placebo.
Primary results were In patients who received AUBAGIO 14 mg, a 43 percent reduction in risk of conversion to CDMS was observedover the two-year study period, compared to placebo (p=0.0087); In patients who received AUBAGIO 7 mg, a 37 percent reduction in risk of conversion to CDMS was observedover the two-year study period, compared to placebo (p=0.0271).
The company noted that the average duration of AUBAGIO exposure in TOPIC was approximately 16 months. Adverse events observed in the trial were consistent with previous clinical trials with AUBAGIO in MS. The most common types of adverse events reported more frequently in the AUBAGIO arms were ALT (Alanine transaminase) elevations, nasopharyngitis, headache, hair thinning, diarrhea and paresthesia.
According to the company, there were no deaths reported in either teriflunomide group over the course of the study. There was one death due to suicide in the placebo arm. The rate of treatment discontinuation due to adverse events was similar across treatment arms (9.1 percent in placebo arm, compared to 12.1 percent in 7 mg teriflunomide arm and 8.3 percent in 14 mg teriflunomide arm).
AUBAGIO is approved in the U.S., Australia and Argentina for the treatment of relapsing forms of MS. Marketing applications for AUBAGIO are also under review by regulatory authorities globally.
AUBAGIO (teriflunomide) is a once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis or MS. AUBAGIO 14 mg has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI.
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