EMEA to review Prexige

EMEA's CHMP said it will review Prexige lumiracoxib from Novartis (NVS; SWX:NOVN) following a notification by the U.K. that the country was considering suspending the osteoarthritis drug's marketing authorization due to possible increased risk of hepatotoxic adverse events at the 100 mg dose. The agency requested additional pharmacovigilance data from NVS to facilitate a review of the COX-2 inhibitor at CHMP's December meeting. An NVS spokesperson said hepatotoxicity is a rare but serious side effect known to occur with COX-2 inhibitors, and that the rate of severe liver events seen with Prexige is "well within the rates expected for drugs of the NSAID class." ...