Multiple sclerosis (MS) treatment Gilenya (fingolimod) has had its prescribing information updated after discussions with the EMA and the FDA.
Novartis has agreed to the updates to provide healthcare professionals with further guidance on initiating its use in patients with MS after reviews by both health regulators following cardiovascular concerns in certain patients.
Patients starting the use of Gilenya should have an electrocardiogram (ECG) and blood pressure measurement prior to the first dose with regular updates and continuous ECG monitoring for a minimum of six hours afterwards.
The CHMP has now confirmed a positive benefit-risk profile for the once-daily oral medication following the label change.
“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.
In additional, the label update in the EU also cautions against Gilenya’s use in patients who may be less tolerant of it or are more likely to develop a significantly slowed or abnormal heart rate because of certain underlying conditions or concomitant medications.
In the EU, Gileyna 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.
The CHMP’s labelling recommendations will be reviewed by the European Commission with a final decision expected in June 2012.
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