Sanofi (SNY) and its subsidiary Genzyme recently announced that their oral candidate for relapsing forms of multiple sclerosis (:RMS), Aubagio (teriflunomide), has received US Food and Drug Administration (:FDA) approval. The FDA approved Aubagio as a once-daily treatment for patients with RMS. Aubagio is currently under regulatory review in the EU. FDA approval came in on encouraging data from a pivotal phase III study (:TEMSO) in patients with RMS. The TEMSO phase III study evaluated Aubagio in two dosage strengths, 7mg and 14mg. Patients in both 7mg and 14mg Aubagio dosage arms demonstrated a 31% reduction in annualized relapse rate compared to placebo. Additionally, the company presented positive results from the phase III TOWER trial, which was conducted on 1,169 patients with RMS. However, we note that in the TENERE trial, reported in December 2011, Aubagio failed to show statistical superiority over Pfizer/Merck KGaAs (PFE/MKGAF) Rebif. There are two more studies in progress, namely TOPIC and TERACLES. Competition in the oral multiple sclerosis market will be intense and Aubagio needs to demonstrate superior efficacy and tolerability to gain share. Novartis (NVS) Gilenya already has a lead in the oral MS market with the product being approved in September 2010. Another … Continue reading
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