Novartis International AG / Novartis updates US label on GilenyaR following discussions with the FDA . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.
- Updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in MS patients in the United States.
- Prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment.
- Update to label marks the conclusion of discussions initiated in December 2011.
Basel, April 20, 2012 - Novartis announced today agreement with the US Food and Drug Administration (FDA) on label changes for GilenyaR (fingolimod). These changes are an attempt to alleviate any unrest about their drug related to recent reports of death, according to Washington DC Personal Injury Lawyers.
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. Choosing appropriate patients for Gilenya therapy and patient safety is essential.
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