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FDA Panel Suggests Removing Warning from Pfizer's Chantix

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Pfizer, Inc.PFE announced that the FDA advisory panels have recommended removing a serious warning about neuropsychiatric side effects on the label of its smoking cessation therapy Chantix.

We remind investors that Chantix's label includes a boxed warning regarding serious neuropsychiatric adverse events, reported in some patients attempting to quit smoking while taking the drug in the post-marketing experience.

The recommendation given at a joint meeting of the FDA's Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee was based on data from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) study.

This randomized, double-blind, active and placebo-controlled study evaluated the neuropsychiatric safety of Chantix/Champix (Chantix's trade name in the EU and other countries) and bupropion, in comparison to placebo and nicotine replacement therapy patch (NRT), in patients with and without a history of psychiatric disorder.

Per data published in The Lancet in April this year, the study did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events in the Chantix arm, compared to placebo and nicotine patch. It also found that smokers treated with Chantix had significantly higher quit rates compared to those treated with bupropion, nicotine patch, or placebo.

The Committees recommended, by a majority vote, to remove the boxed warning from Chantix's label. Pfizer had submitted a supplemental New Drug Application (sNDA) to the FDA earlier this year, requesting updates to the label to include safety and efficacy data from the EAGLES study and removal of the boxed warning.

In May this year, the EU label of Champix was updated to include safety and efficacy data from the EAGLES study. Also, the black triangle symbol, which indicated that additional safety monitoring for Champix in the EU was required, was removed.

We note that the EAGLES study was conducted by Pfizer in collaboration with GlaxoSmithKline plc GSK , in consultation with the FDA as well as the European Medicines Agency.

The FDA is not obligated to follow the recommendations of its panel, but usually it does.

Stocks to Consider

Currently, Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Johnson & Johnson JNJ) and Geron Corporation GERN . While Geron sports a Zacks Rank #1 (Strong Buy), J&J has a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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