Novartis AG, manufacturer of the drug, Gilenya (fingolimod), confirmed this week that a 59 year old patient suffering from multiple sclerosis passed away after beginning treatment with the drug, the first of its kind to be approved by the FDA to treat the neurological disease. Novartis noted that this is the first reported death to occur within 24 hours of the first dose of Gilenya in more than 28,000 patients. Regardless, due to these recent events, the safety of the drug is now being questioned.

It is no secret that Novartis had high hopes for Gilenya, projecting that it would become the company’s next blockbuster product. After all, successful sales numbers for Gilenya could provide a much-needed earnings boost for Novartis, especially considering the fact that patents on several of the company’s best selling drugs will soon expire.

Novartis has reportedly submitted details of the case to the FDA for review. The patient who died started treatment with Gilenya on November 22 and was monitored without incident for six hours after taking the first dose. With MS drugs, patients are often susceptible to a long list of potential adverse events and safety issues.

(Source: Bloomberg.com 12/13)