The FINANCIAL — Pfizer Inc. on May 23 announced that the European Summary of Product Characteristics (SmPC) and Package Leaflet for CHAMPIX (varenicline) have been updated to include safety and efficacy data from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial.
As part of the update, the black triangle symbol, which indicated that additional safety monitoring for CHAMPIX in the EU was required, has been removed. EAGLES is a post-authorization safety study/post-marketing requirement study, which was conducted in 16 countries and designed to evaluate the neuropsychiatric safety of CHANTIX/CHAMPIX and bupropion versus placebo and nicotine replacement therapy patch (NRT) in patients with and without a history of psychiatric disorder. The outcomes of the EAGLES trial were recently published in The Lancet. The CHAMPIX EU label update was implemented following the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, according to Pfizer.
“Smoking remains a major public health challenge, causing more than 5 million deaths worldwide each year,” said Rory O’Connor, MD, Chief Medical Officer, Internal Medicine, Pfizer Inc. “Since its introduction in the EU nearly 10 years ago, CHAMPIX has been prescribed to millions of adults to help them stop smoking. The new safety and efficacy information in the European label further supports the importance of CHAMPIX as a treatment option for healthcare providers and for those who are trying to quit smoking.”
The EAGLES trial is a large randomized, double-blind, active and placebo-controlled study that was conducted by Pfizer in collaboration with GlaxoSmithKline at the request of, and designed in consultation with, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. The primary safety endpoint was a composite of neuropsychiatric adverse events that have been reported in the post-marketing experience for CHANTIX/CHAMPIX. The study also included an efficacy objective to determine smoking abstinence rates in patients treated with CHAMPIX or bupropion, relative to placebo, during the last four weeks of treatment.
The European Medicines Agency approval to update the CHAMPIX label applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. The EAGLES data are currently under review by other regulatory authorities worldwide.
The CHANTIX/CHAMPIX labeling globally includes a boxed warning/warning regarding serious neuropsychiatric adverse events that have been reported in some patients attempting to quit smoking while taking CHANTIX/CHAMPIX in the post-marketing experience. Some people have had changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions while using CHANTIX/CHAMPIX to help them quit smoking. If the CHANTIX/CHAMPIX patient, their family or caregiver notices any of these symptoms or behaviors, they should stop taking CHANTIX/CHAMPIX and call their doctor right away. They should tell their doctor about any history of depression or other mental health problems, which could get worse while taking CHANTIX/CHAMPIX.
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