Novartis drug Gilenya (fingolimod) has more than 20,000 patient-years of exposure

Gilenya (fingolimod) shows up to 71% reduction in annualized relapse rates in MS patients with highly active disease

19-Oct-2011 - Switzerland

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 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), 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."

Data highlights include:

Fingolimod 0.5 mg significantly reduced annualized relapse rates (ARR) by up to 71% (from 61% to 71%) compared to interferon beta-1a IM and compared to placebo in relapsing-remitting multiple sclerosis (MS) patients with high disease activity despite previous MS disease-modifying treatment. Although the reduction in ARR in another subgroup of patients, those patients with rapidly evolving severe relapsing-remitting MS, was directionally consistent with other subgroup data, statistical significance was not achieved compared to interferon beta-1a IM due to the small number of patients in this subgroup.
In relapsing-remitting MS patients with high disease activity despite previous MS disease-modifying treatment, the relative reduction of ARR ranged from 61% compared to interferon beta-1a in TRANSFORMS to 62%-71% compared to placebo in FREEDOMS.
In the European Union, Gilenya 0.5 mg is approved for the treatment of relapsing-remitting MS in patients with high disease activity despite treatment with interferon beta, and in patients with rapidly evolving severe relapsing-remitting MS.
Fingolimod 0.5 mg reduced the rate of brain atrophy, or brain volume loss, compared to interferon beta 1a IM over 12 months, irrespective of disease activity prior to study start as shown in an analysis of the pivotal Phase III TRANSFORMS study.
A five year Phase II study extension showed that patients with relapsing MS treated with fingolimod maintained low disease activity with a safety profile consistent with that seen in other fingolimod clinical trials. Of the original 281 patients at the start of the Phase II study, approximately 50% (140 patients) completed five years of treatment.

https://www.bionity.com/en/news/134868/novartis-drug-gilenya-fingolimod-has-more-than-20-000-patient-years-of-exposure.html