Novartis updates US label on Gilenya following discussions with the FDA

Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment

Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for Gilenya (fingolimod).

The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The update marks the conclusion of discussions initiated in December 2011.

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted.

As of February 2012, approximately 36,000 patients have been treated with Gilenya in clinical trials and in the post-marketing setting.

"Gilenya represents an important treatment option for relapsing forms of MS," said Barry Singer, Director, MS Center for Innovations in Care, Missouri Baptist Medical Center. "Choosing appropriate patients for Gilenya therapy and patient safety is essential."

If therapy is interrupted for patients who are already taking Gilenya, they should undergo the new recommended monitoring upon treatment re-initiation as per the revised recommendations on the duration of interruption depending on duration of prior treatment. Patients should not make any changes to any medications they are taking, including Gilenya, without consulting their doctor.

The label update in the US for Gilenya recommends that patients with certain pre-existing cardiac conditions or those taking certain concomitant medications would require overnight monitoring following administration of first dose of medication, and for some patients prior evaluation with a specialist. Experience with the use of Gilenya in such patients was limited in the pivotal clinical trials.

Gilenya is contraindicated in patients with history or presence of certain cardiac conditions, including heart attack or stroke in the past six months, second- and third-degree AV block and other serious cardiac rhythm disturbances, and in patients treated with certain anti-arrhythmic drugs.