Pfizer's Champix gets CHMP positive opinion

US drug giant Pfizer says that it has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), regarding the approval of the smoking cessation product Champix (varenicline). The drug, which is known under the trade name Chantix in the USA, received Food and Drug Administration clearance as an anti-smoking aid earlier this year (Marketletter May 22).

Trials of the drug demonstrated that it brought about cessation rates that were nearly four times those achieved with placebo. In addition, the assessment showed that the drug was generally well tolerated, and had a withdrawal rate that was similar to placebo.

Pfizer's chief medical officer, Joseph Feczko, said that the CHMP had recognized the product's potential as a therapy for a major public health issue.