Gilenya Successfully Treated Relapsing MS Patients For Up To 7 Years

Editor's Choice Main Category: Multiple Sclerosis Article Date: 24 Apr 2012 - 0:00 PDT

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Gilenya (fingolimod) is the only oral therapy approved to treat relapsing forms of multiple sclerosis (MS)1,2. It is the first in a new class of sphingosine 1-phosphate receptor (S1PR) modulating compounds and has demonstrated superior efficacy over Avonex (interferon-beta-1a IM), a commonly prescribed treatment.

In a pivotal head-to-head trial in patients with relapsing- remitting multiple sclerosis at one year, Gilenya achieved both its primary and secondary endpoints, i.e. a 52% relative reduction of the yearly relapse rate and a 40% relative reduction in the rate of brain atrophy. A recent sub-analysis at one year revealed that in comparison to interferon-beta-1a (IM), Gilenya achieved a 61% relative reduction in the rate of yearly relapses in patient subgroups with highly active relapsing-remitting MS patients who previously received interferon therapy.

Gilenya has no label restrictions specific to treatment duration and was generally well tolerated during clinical trials with a manageable safety profile. Since February 2012, over 36,000 patients have been treated with Gilenya in clinical trials and in the post-marketing setting, which confirms Gilenya's long- term effectiveness and safety profile. 2,400 patients have been taking the drug for longer than two years.

The most common adverse events reported were cough, diarrhea, headache, liver enzyme elevations and back pain, whilst other side effects included a mild increase in blood pressure, transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, macular edema, and mild bronchoconstriction.

Overall, the rates of infections including serious events were similar in all treatment groups. However, patients treated with Gilenya reported a slightly higher rate of respiratory tract infections that consisted mainly of bronchitis. There were only a small number of reported malignancies in the clinical trial, with similar rates between the Gilenya and control groups.

The double blind, two-year FREEDOMS 24 core study involved a total of 1,033 patients, of which 90% completed 3 years of monitoring and 45% who were followed up for 4 years before being transferred to the umbrella follow-up study (LONGTERMS).

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Gilenya Successfully Treated Relapsing MS Patients For Up To 7 Years