Pfizer Inc has announced that, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency issued a positive opinion, recommending marketing authorization of Champix (varenicline), a novel pill for the treatment of smoking cessation.
The CHMP's positive recommendation will be reviewed by the European Commission, which has authority to approve medicines for the European Union. Pfizer anticipates a final decision from the Commission in the coming months.
Pfizer discovered and developed, Champix is a pill specifically designed as an aid to smoking cessation. Champix is believed to work by reducing the severity of the smoker's craving and many withdrawal symptoms from nicotine.
"Globally, it is expected that half a billion people alive today will die from smoking-related causes," stated Dr Joseph Feczko, Pfizer's chief medical officer. "Champix represents a significant new discovery in the arena of smoking cessation research. Pfizer is pleased that the CHMP has recognized the potential therapeutic benefit of Champix in addressing this serious public health issue."
Smoking, the leading cause of preventable death worldwide, is responsible for five million deaths worldwide each year. In Europe alone, more than 1.2 million people die each year from a smoking related disease. By 2010, the WHO estimates the annual global cost of tobacco-related illness to be approximately $500 billion.
"When it comes to smoking, preventive medicine is truly the best medicine. Smoking harms nearly every organ in the body and is the cause of many diseases including cardiovascular disease, cancer and respiratory disease," said Dr Serena Tonstad, Champix clinical trial investigator and head physician, Department of Preventive Cardiology, Ulleval University Hospital, Norway. "Helping smokers quit is one of the most important things, a physician can do to improve their patients' overall health and reduce their risk of developing serious chronic conditions."
The medication, varenicline, with Chantix (varenicline) in the US, received US FDA approval as an aid to smoking cessation in May 2006. In clinical trials, varenicline was generally well tolerated with overall discontinuation rates similar to placebo. The most frequent side effects included nausea, headache, trouble sleeping and changes in dreaming.