This week, Novartis AG informed the U.S. Food and Drug Administration and other regulatory agencies that a 59 year old patient suffering from multiple sclerosis passed away after beginning a treatment with the drug Gilenya (fingolimod), the first pill approved by the FDA to treat the neurological disease.
The drug, which was approved for use in the U.S. just last year, has already been given to more than 28,000 patients. However, due to recent events, the drug’s safety is now being called into question. While Gilenya’s role in the patient’s death remains unclear, it was still the first passing reported within 24 hours of starting treatment with the drug.
The drug’s maker, Novartis AG, had high hopes for Gilenya, projecting it would become the company’s next blockbuster product. After all, sales of the drug 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)
