Gilenya was developed by drug maker Novartis to combat multiple sclerosis, but now the drug is being reviewed after 11 people died after taking their first dose. According to NewsCore, both the European Medicines Agency and the U.S. Food and Drug Administration are taking steps to ensure that the drug is safe for patients.
The European Medicines Agency said it was prompted to review the “benefits and risks” of Gilenya after multiple reports of heart problems were reported in patients taking the drug. It expects the review to be complete by March.
As for the FDA, the agency announced its review of Gilenya in December, but has not yet given a time frame for its completion.
Both agencies pointed to the November death of a 59-year-old American patient as the first cause of concern with the drug. The patient died less than 24 hours after the first dose of Gilenya was administered, NewsCore said. Neither agency has stated a clear reason for the patient’s death.
Since then, 10 more deaths have been reported in connection with the drug. Six were unexplained, three were the result of a heart attack and one was due to a disruption of heart rhythm.
Gilenya was developed as the first oral treatment for MS, Business Week noted. Shares in Novartis fell four percent on the news of the European review.
