FDA weighs benefits, risks of Novartis MS pill
The Associated Press: FDA weighs benefits, risks of Novartis MS pill
Swiss drugmaker Novartis has asked the Food and Drug Administration to approve its drug Gilenia to treat patients with relapsed multiple sclerosis, which causes tremors and movement problems. The drug is a daily pill and would offer an alternative to older injectable drugs.
FDA reviewers said two studies of the drug “provide substantial evidence for an effect.”
However, FDA staff also noted a number of side effects with the drug, including eye disorders, heart problems and weakened lung function.
Serious side effects occurred in at least 8.5 percent of patients taking Novartis’ drug, compared with 5.8 percent of patients taking older multiple sclerosis drugs.
FDA reviewers complained that there was little data on the long-term effects of using Gilenia.