Pfizer Inc 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.
1 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.2 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.
“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.
CHANTIX® (also known as CHAMPIX® in the EU and other countries) was approved by the FDA in May 2006 as a prescription medication that, along with support, helps adults 18 and over stop smoking. Adults who smoke may benefit from quit-smoking support programs and/or counseling during their quit attempt. It’s possible that patients might slip up and smoke while taking CHANTIX/CHAMPIX. If patients slip up, they can stay on CHANTIX/CHAMPIX and keep trying to quit.
About Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.
1 Champix® (varenicline): EU Summary of Product Characteristics. Pfizer; May 2016.
2 Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomized, placebo-controlled clinical trial. Lancet. 2016 Apr 19:e1-e14..
Steven Danehy, 212-733-1538
Investors:Charles Triano, 212-733-3901