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CHMP confirms Gilenya positive benefit-risk balance


Novartis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed a positive benefit-risk profile of once-daily oral Gilenya® (fingolimod).

Novartis and the CHMP have agreed to recommended updates to the product information in the European Union in order to provide further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients. The changes follow the Article 20 review by the EMA announced in January 2012.

In the European Union, all MS patients initiating treatment with Gilenya should have an electrocardiogram (ECG) and a blood pressure measurement prior to the first dose of the medicine and after the six-hour first-dose monitoring period. Blood pressure and heart rate should be measured every hour during this period, and continuous ECG monitoring is recommended for a minimum of six hours following the first dose.

“We believe that Gilenya is a valuable treatment option for many patients with relapsing remitting MS, and we welcome the confirmation of the positive benefit-risk profile of the drug which also supports our continued belief of the blockbuster potential of Gilenya,” said David Epstein, Division Head of Novartis Pharmaceuticals. “MS is a devastating chronic disease that affects more than 2.1 million people worldwide, and patients need effective treatment options.”

As of February 2012, approximately 36,000 patients have been treated with fingolimod in clinical trials and in the post-marketing setting, some up to seven years, and currently there is approximately 34,000 patient years of exposure. In the European Union, Gilenya is approved for people with highly active relapsing-remitting MS despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.

More about the CHMP recommended label update

Extended ECG monitoring is required after first-dose of Gilenya for patients who have very low or their lowest measured heart rate at the six hour time point, and in patients who have symptomatic bradycardia (low heart rate) or ECG abnormalities at any time during the six hour monitoring.

In addition, the recommended label update in the European Union cautions against use in patients who may be less tolerant of or are more likely to develop significantly slowed or abnormal heart rate because of certain underlying conditions or concomitant medications. If treated, these patients would require overnight monitoring. Experience with the use of Gilenya in such patients was limited in the pivotal clinical trials.

The new first-dose observation recommendations do not affect patients who are already taking Gilenya. If therapy is interrupted for more than two weeks, patients should undergo the new recommended monitoring upon treatment re-initiation. Patients should not make any changes to any medications they are taking, including Gilenya, without consulting their doctor.

The CHMP labeling recommendations will be reviewed by the European Commission with a final decision expected in June 2012. Novartis will inform physicians in the European Union of the changes in the product information in the EU via a Direct Healthcare Provider Communication (DHPC) by end of April 2012.

About Gilenya® (fingolimod)

Gilenya, licensed from Mitsubishi Tanabe Pharma Corporation, is the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. It has demonstrated superior efficacy compared to Avonex® (interferon-beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction in annualized relapse rate (primary endpoint) and a 40% relative reduction in the rate of brain atrophy (secondary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis. In a recent sub-analysis, Gilenya showed a 61% relative reduction in annualized relapse rate compared to interferon-beta-1a (IM) at one year in subgroups of patients with highly active relapsing-remitting MS patients previously treated with interferon.

Gilenya is generally a highly effective once-daily oral MS treatment without label restrictions specific to treatment duration. In clinical trials it was generally well tolerated with a manageable safety profile, and there is increasing experience of Gilenya’s long-term effectiveness and safety profile, with more than 36,000 patients having been treated as of February 2012 in clinical trials and in the post-marketing setting, 2,400 patients having been on treatment for more than two years. In clinical trials, the most common side effects were headache, liver enzyme elevations, influenza, diarrhea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction.

The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups.

As part of the Novartis commitment to transparency, the Gilenya Information Centre has recently been launched. For more information please visit the Gilenya information site at



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