Mon Oct 17, 2011 1:15am EDT
Novartis International AG / Novartis drug Gilenya® (fingolimod) has more than 20,000 patient-years of exposure and shows up to 71% reduction in annualized relapse rates in MS patients with highly active disease . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
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Analyses presented at 5th Joint Triennial Congress of ECTRIMS and ACTRIMS showed relapse rate reductions were consistent among subgroups of fingolimod-treated patients that had highly active disease in pivotal clinical trials
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Fingolimod demonstrated reductions in rates of brain atrophy compared to interferon beta-1a IM regardless of disease activity
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To date, approximately 25,000 patients treated with fingolimod and more than 20,000 patient-years of exposure; more than 20,000 patients on commercial drug
Basel, October 17, 2011 – Novartis will showcase data from 13 abstracts on fingolimod (Gilenya®), at the 5th Joint Triennial Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) taking place from 19-22 October in Amsterdam.
The data being presented for fingolimod at ECTRIMS/ACTRIMS highlight the Novartis clinical trial program for sphingosine 1-phosphate receptor (S1PR) modulators. Fingolimod targets MS via effects on the immune system and new pre-clinical data to be presented at ECTRIMS/ACTRIMS supports an additional potential direct effect on the central nervous system (CNS)[1,2], although the clinical relevance of this remains to be determined. Additional clinical data describe efficacy in subgroups of patients with highly active disease in the pivotal Phase III studies.
“Gilenya has already demonstrated significant efficacy in large scale clinical trials which is reinforced by these important data presented at ECTRIMS/ACTRIMS reflecting different patient populations in need of a new treatment,” said David Epstein, Head of the Pharmaceuticals Division at Novartis Pharma AG. “These findings will help further solidify the role of Gilenya in the treatment of MS within its approved indication.”
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