US FDA reviewers see Novartis' Gilenia as effective, but with safety issues; Agency accepts Depomed's filing for DM-1796

Ahead of an advisory panel meeting tomorrow (June 10), the US Food and Drug Administration has indicated that, while Novartis' investigational oral multiple sclerosis candidate Gilenia (fingolimod; FTY720) is effective, there are some safety issues to be considered, according to US media reports.

As recently as last month, the FDA put back the review date for the Swiss drug major's product to September (The Pharma Letter May 25), and this week rival Merck KGaA announced that it has resubmitted its New Drug Application of its oral MS candidate cladribine, for which the agency has previously issued a 'refuse to file' letter (TPL June 8).

According to an Associated Press report, the FDA reviewers said two studies of the drug "provide substantial evidence for an effect." However, they also noted a number of side effects with the drug, including eye, lung and heart problems.
Serious side effects occurred in at least 8.5 %of patients taking Novartis' drug, compared with 5.8% of those using older multiple sclerosis drugs. FDA reviewers also complained that there was little data on the long-term effects of using Gilenia, said the AP.