Champix varenicline regulatory update

EMA's CHMP concluded the slightly increased risk of cardiovascular events reported from a meta-analysis of Champix varenicline from Pfizer does not outweigh the benefits of the smoking cessation drug. CHMP said it could not draw a robust conclusions from the study for which it identified a number of limitations, including the low number of events observed, the types of events counted, the higher drop out rates in the placebo arm, lack of information on the timing of events and exclusion of studies in which no patients had an event. CHMP requested Pfizer submit a variation to include more information on cardiovascular events. According to the agency, the pharma plans to submit the application in early August. CHMP plans to review the application and make a recommendation at its Sept. 19-22 meeting. In July, researchers at Johns Hopkins University School of Medicine reported data from a meta-analysis of 14 double-blind clinical trials in 8,216 patients showing that varenicline was associated with a significantly increased risk of serious adverse cardiovascular events compared to placebo (1.06% vs. 0.82%, p=0.02) (see BioCentury, July 11). ...