EMA limits use for MS pill Gilenya
23.04.2012 - Novartis' multiple sclerosis pill Gilenya will have its label updated in the EU, enabling physicians to better manage potential adverse effects on the heart.
London – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that all patients beginning treatment with Gilenya (fingolimod) should have an electrocardiogram before taking the first dose and for six hours after. The body also recommends regular blood pressure and heart rate monitoring. The CHMP advises that heart activity monitoring should be extended for patients whose heart rate is lowest six hours after receiving the first dose, and that patients who develop clinically significant problems like bradycardia or atrioventricular block should be monitored until the problems have been resolved. The CHMP also adds that doctors should no longer prescribe the drug to patients with cardiovascular and cerebrovascular disease, or to patients on heart-rate lowering medications. But if these patients must receive Gilenya, their heart activity must be monitored at least over night after taking the first dose
Gilenya has been authorised in the European Union (EU) since March 2011 for the treatment of relapsing-remitting MS in patients who have not responded to treatment with beta-interferon or whose disease is severe and getting worse rapidly. It is the first disease-modifying MS treatment available as an oral formulation.
The EMA began a review of the drug in January following reports of heart problems in patients taking Gilenya. The CHMP looked at all available data on heart safety, including reports of 15 cases of sudden or explained death in patients treated with Gilenya. Most deaths occurred in patients with cardiovascular problems or those taking other medicines. However, it is still not clear if Gilenya was the cause of death. According to Novartis, some 36,000 patients have received treatment with Gilenya since February