Regulators in Europe have backed continued use of Novartis' multiple sclerosis pill Gilenya, but insisted on updating its label to include more information on cardiovascular risk.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has completed its review on Gilenya (fingolimod), which began in January following the unexplained sudden death in a patient within 24 hours of taking the pill for the first time. The CHMP now recommends that doctors should not prescribe Gilenya to patients "with a history of cardiovascular and cerebrovascular disease or who take heart-rate lowering medication".
However, when treatment is considered necessary in these patients, their heart activity should be monitored at least overnight following the first dose and doctors should seek advice from a cardiologist on appropriate monitoring, the EMA says. The CHMP also recommends that all patients starting treatment with Gilenya should have their heart activity monitored before receiving the first dose and continuously for at least six hours after.
For this review, the CHMP says it has assessed all available data on the heart safety of Gilenya, including reports of 15 cases of sudden or unexplained death in patients treated with the drug. The committee noted that most of the deaths and heart problems had occurred in patients with a history of cardiovascular disease or taking other medicines and the data reviewed were not conclusive as to whether Gilenya was the cause of the deaths.
The CHMP also noted the maximum effect of Gilenya on decreasing the heart rate occurred within six hours after the first dose in most patients and that this decrease in heart rate can be reversed if necessary by giving atropine or isoprenaline. It concluded that "with these risk-minimisation measures in place…the benefits of Gilenya continue to outweigh the risks".
David Epstein, head of Novartis Pharmaceuticals, said "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".
Last week, a patient taking the pill was diagnosed with a rare brain disease, although Novartis stressed that the individual had previously been treated with Biogen Idec/Elan’s MS drug Tysabri (natalizumab), which has already been associated with the rare disease progressive multifocal leukoencephalopathy.