Sanofi’s Genzyme presents positive phase 3 data for MS drug

Hannah Blake

pharmaphorum

Genzyme, a subsidiary of Sanofi, has announced key data from its phase 3 clinical trials of its multiple sclerosis drug, Aubagio.

The trials, called TOWER (Teriflunomide Oral in people With relapsing multiplE scleRosis), involved 1,168 patients with relapsing MS across 26 countries. The trials compared 7mg or 14mg once-daily, oral aubagio against placebo.

In the study, the once-daily, oral Aubagio 14 mg was found to significantly reduce the yearly relapse rate and slow 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.

“Slowing the progression of disability is a major goal in treating MS and remains a significant unmet need for many patients. 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.”

Ludwig Kappos, M.D., Chair of Neurology, University Hospital Basel, Switzerland, who presented the key TOWER results.

Genzyme are now moving towards refilling its FDA application for its other MS drug, Lemtrada.

"We are on track to satisfy the questions of navigability from the FDA. We are also having interactions with regulators around the world which are very favorable."

Michael Panzara, therapeutic area head for multiple sclerosis and immune diseases at Genzyme.