Novartis Investigating Death After First Fingolimod Dose

  Novartis Investigating Death After First Fingolimod Dose

Novartis Pharmaceuticals has confirmed that the company is investigating the death of a patient with multiple sclerosis (MS) that occurred the day after the patient received a first dose of fingolimod (Gilenya).

"Novartis has been notified that on 23 November 2011, a patient died who had received the first dose of Gilenya on the previous day," a spokesperson for Novartis said in an emailed comment to Medscape Medical News. "The patient had successfully completed 6 hours of postdose observation without incident."

The approval in September 2010 by the US Food and Drug Administration (FDA) of the drug, the first oral MS treatment, called for monitoring after a first dose because of the risk for bradycardia reported in premarketing trials of fingolimod.

This is the first reported death occurring within 24 hours of the first dose of fingolimod in the more than 28,000 patients who have received the drug to date, the Novartis statement adds.

"At this stage, the exact cause of death has not been established, and a role for Gilenya can be neither confirmed nor excluded at this time," the company said.

"Novartis takes patient safety very seriously, and we are currently gathering all available details on this case," the spokesperson added. Details have been submitted to the FDA, she said, as well as other health authorities, "in accordance with required regulatory reporting processes."

Fingolimod is approved to reduce relapses and delay disability progression in patients with MS. The approval included a risk evaluation and mitigation strategy to manage adverse events seen with the drug in clinical trials including bradycardia on first treatment; macular edema; increased risk for infection, including herpes infection; and increased liver enzymes. Two patients died of herpes infection during premarketing clinical trials.

REFERENCE:MEDSCAPE