Pfizer Champix's Label To Include More Data, Warning Lifted

Pfizer Inc. (NYSE:PFE) announced that European regulators have lifted a warning on the company's smoking cessation drug, Champix, known as Chantix in the U.S.

The company said that the European Summary of Product Characteristics (SmPC) and Package Leaflet for Champix have been updated to include data from the EAGLES study.

The label update was implemented after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion. As a result, the black triangle symbol, indicating the requirement of additional safety monitoring for the drug in the EU, has been removed.

Meanwhile, data from the EAGLES study is under review by other regulatory authorities across the world.

The randomized, double-blind, active and placebo-controlled EAGLES study evaluated the neuropsychiatric safety of Chantix/Champix and bupropion, in comparison to placebo and nicotine replacement therapy patch (NRT), in patients with and without a history of psychiatric disorder. Results from the study were published in The Lancet in Apr 2016.

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

Chantix is currently approved in the U.S. as a prescription medication that, along with support, helps adults 18 and over to quit smoking.

We remind investors that Chantix/Champix’s label includes boxed warning/warning regarding serious neuropsychiatric adverse events that were reported in some patients who attempted to quit smoking while taking the drug in post-marketing experience.

In the first quarter of 2016, Chantix/Champix generated sales of $220 million, up 39.2% year over year.

Pfizer currently sports a Zacks Rank #1 (Strong Buy). Other top-ranked stocks in the health care sector include Bristol-Myers Squibb Company (NYSE:BMY) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . Both stocks sport the same Zacks Rank as Pfizer.

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