The UK's Medicines and Healthcare products Regulatory Agency's latest ‘drug safety update’ (February) flags the increased cardiovascular monitoring required when patients are given their first dose of Novartis' oral multiple sclerosis drug Gilenya.
A review by the European Medicines Agency of the benefits and risks of Gilenya (fingolimod) is due to report mid-March. The EMA review followed reports of heart problems in patients taking Gilenya, as well as the death of one patient in the USA less than 24 hours after the first dose. The exact cause of this patient’s death remains unexplained.
In an unusual move, Novartis opted for ‘total disclosure’ during its earnings call briefing last month. David Epstein, head of Novartis Pharmaceuticals, said that in the interests of full transparency, he would disclose all-cause mortality for Gilenya, a step he described as "unprecedented" in this therapeutic area.
He said that since 2003, there had been a total of 31 MS deaths amongst the 30,000 patients treated with the drug. “When we compare our data overall with the background rate of overall death as well as cardiovascular death in comparable populations, we see no imbalances whatsoever. Also when we look at our controlled clinical trials, which cover thousands of patients over several years, we see the rate of death is not elevated when compared to placebo,” Mr Epstein said.
“We are confident that Gilenya has a strong benefit risk profile, and we believe this brand will continue to provide significant growth to our company,” he added. Gilenya sales in 2011 reached $494 million, and Novartis believes it will become a blockbuster in the not-too-distant future. Reaching that level will hang in part on the EMA review, due to report on March 16.