Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY) announced today that key data from the TOWER trial were presented at the 28 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). In the study, once-daily, oral AUBAGIO ® 14 mg significantly reduced the annualized relapse rate and slowed progression of disability in patients with relapsing forms of multiple sclerosis (MS) compared to placebo. In addition, the proportion of patients treated with AUBAGIO who were relapse-free was significantly higher compared to placebo.
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TOWER ( Teriflunomide Oral in people With relapsing multipl E scle Rosis) is a randomized, double-blind Phase III trial that enrolled 1,169 patients with relapsing MS across 26 countries and compared 7 mg or 14 mg once-daily, oral AUBAGIO against placebo. The company announced positive top-line results in June. In September, the FDA approved AUBAGIO as a once-daily oral treatment for patients with relapsing forms of MS. Marketing applications for AUBAGIO are currently under review by the EMA and other regulatory authorities.
“Slowing the progression of disability is a major goal in treating MS and remains a significant unmet need for many patients,” said Ludwig Kappos, M.D., Chair of Neurology, University Hospital Basel, Switzerland, who presented the key TOWER results. “The TOWER study results are consistent with the Phase lll TEMSO data, both in terms of the effect on progression of disability and the manageable safety profile of AUBAGIO.”
TOWER data presented for the first time today for the 14 mg dose include:
- A 36.3 percent reduction in annualized relapse rate (ARR=0.319), the primary endpoint of the trial, as compared to placebo (ARR=0.501) (p=0.0001); Fifty-two percent of patients treated with this dose were also relapse-free, meaning they did not experience any relapses during the study, compared to 38 percent with placebo (37 percent risk reduction; p<0.0001).
- A 31.5 percent reduction in the risk of 12-week sustained accumulation of disability, the main secondary endpoint, as measured by the Expanded Disability Status Scale (EDSS), compared to placebo (p=0.0442).