FDA advisory committees recommend to remove boxed warning in labeling for Pfizer’s smoking cessation therapy, Chantix

Earlier this year, Pfizer submitted to the FDA a supplemental New Drug Application (sNDA) requesting updates to the Chantix labeling based on the safety and efficacy outcomes of EAGLES. In addition to requesting removal of the boxed warning, Pfizer proposed retaining the Warnings and Precautions section in the labeling regarding serious neuropsychiatric events occurring in patients attempting to quit smoking and updating it with EAGLES data. Pfizer believes that such a warning would sufficiently inform prescribers of the possibility that these types of events may occur.

EAGLES is a randomized, blinded, placebo-controlled clinical trial, which was conducted by Pfizer in collaboration with GlaxoSmithKline and at the request of and designed in consultation with the FDA and the European Medicines Agency. The study is the first and largest to compare the safety and efficacy of all three currently approved smoking cessation therapies, including Chantix, in more than 8,000 smokers with and without a history of psychiatric disorders. It included a novel composite primary endpoint developed by Pfizer with input from the FDA, comprised 16 components reflecting the type of events reported in the Chantix postmarketing experience and included in the labeling.

“The totality of available scientific evidence, including the outcomes of EAGLES, supports the safety and efficacy of Chantix, and we look forward to the FDA’s decision on the Chantix labeling,” said Freda Lewis-Hall, Chief Medical Officer and EVP, Pfizer Inc. “We are pleased with the Committees' recommendation to remove the boxed warning and believe this is an important step toward updating the Chantix labeling to more accurately reflect its neuropsychiatric safety profile and help patients and prescribers make informed decisions about treatment options.”