MS Drug Gilenya Positive Benefit-Risk Profile Following CHMP Review, Europe

Editor's Choice Main Category: Multiple Sclerosis Also Included In: Regulatory Affairs / Drug Approvals Article Date: 23 Apr 2012 - 11:00 PDT

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In agreement with the CHMP, the company has updated their E.U. product information after the Article 20 review the EMA announced in January 2012, in order to offer further guidance to healthcare providers who want to initiate using Gilenya in MS patients. In the E.U., Gilenya is approved for the treatment of individuals with highly active relapsing-remitting MS, regardless of treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.

Gilenya 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.

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MS Drug Gilenya Positive Benefit-Risk Profile Following CHMP Review, Europe