• 16
  • February
    2012

A new drug to treat multiple sclerosis that pharmaceutical giant Novartis AG is hoping will bring it billions of dollars in revenue in coming years could cause heart problems in patients, according to regulators in the U.S. and the European Union. So far, the FDA has advised doctors to observe MS patients after they receive their first dose of the drug, called Gilenya, to see if they develop any problems. The EU's European Medicines Agency has gone even further: it is recommending that doctors use an electrocardiogram to monitor patients' heart activity for at least six hours after the initial dose of Gilenya.

The concerns of Gilenya's effect on the heart come after several reports of patient incidents, including one 59-year-old U.S. man who died less than 24 hours of taking Gilenya for the first time. The FDA announced on Dec. 20 that it was investigating the death.

The problem appears to be that the drug depresses the heart rate in patients. While most patients' heart rates return to normal within a few hours, the possibility that some patients will suffer cardiac arrest or other, potentially fatal, side effects has regulators worried. It is not clear why the EMA is advocating stronger patient monitoring than the FDA.

Novartis is banking on Gilenya and other new drugs to replace its lines of products with patents that are about to expire, meaning that generic versions will enter the market. Gilenya alone is expected to provide the company with $1.8 billion in annual revenue by 2016. So far, more than 30,000 people worldwide have received Gilenya for treatment of MS, a chronic disease that affects the central nervous system. Patients with MS can develop paralysis, numbness and blindness.

Source: Reuters, "EU says Novartis MS drug needs heart monitoring," Ben Hirschler and Katie Reid, Jan. 20, 2012