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Pfizer Chantix Label Warning Lifted in U.S.; to Add New Data
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Pfizer, Inc. (PFE - Free Report) announced that the FDA has lifted a boxed warning about neuropsychiatric side effects from the label of its smoking cessation drug, Chantix.
We remind investors that Chantix’s label included 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.
Pfizer shares have risen 2.2% this month so far, underperforming a gain of 3.2% for the Zacks classified Large-Cap Pharma industry.
Coming back to Chantix, in addition to the removal of the boxed warning, its label has been updated to include data from the EAGLES study. The label revisions include updates to the corresponding warning regarding neuropsychiatric safety and the addition of information on the superior efficacy of Chantix versus bupropion or nicotine patch. The drug’s label was updated after the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee, by a majority vote, recommended the removal of the boxed warning this September.
EAGLES is a randomized, double-blind, active, placebo-controlled study that evaluated neuropsychiatric safety of Chantix/Champix (Chantix’s trade name in the EU and other countries) and bupropion, compared to placebo and nicotine replacement therapy patch (NRT), in patients with or without a history of psychiatric disorder.
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 bupropion, nicotine patch or placebo.
Pfizer had submitted a supplemental New Drug Application (sNDA) to the FDA earlier this year, requesting for the inclusion of safety and efficacy data from the EAGLES study, and removal of the boxed warning.
In May 2016, Champix’s EU label was updated to include safety and efficacy data from the EAGLES study. Further, the black triangle symbol, which indicated the requirement of additional safety monitoring for Champix, was removed.
We note that the EAGLES study was conducted by Pfizer in collaboration with GlaxoSmithKline plc (GSK - Free Report) , in consultation with the FDA as well as the European Medicines Agency.
In the third quarter of 2016, Chantix/Champix generated sales of $198 million, up 24% year over year.
Pfizer carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Heska Corporation and Cambrex Corporation . Both these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 over the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 80.6% year to date.
Cambrex’s earnings estimates increased 4.1% for 2016 and 5.2% for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 15.3% year to date.
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Pfizer Chantix Label Warning Lifted in U.S.; to Add New Data
Pfizer, Inc. (PFE - Free Report) announced that the FDA has lifted a boxed warning about neuropsychiatric side effects from the label of its smoking cessation drug, Chantix.
We remind investors that Chantix’s label included 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.
Pfizer shares have risen 2.2% this month so far, underperforming a gain of 3.2% for the Zacks classified Large-Cap Pharma industry.
Coming back to Chantix, in addition to the removal of the boxed warning, its label has been updated to include data from the EAGLES study. The label revisions include updates to the corresponding warning regarding neuropsychiatric safety and the addition of information on the superior efficacy of Chantix versus bupropion or nicotine patch. The drug’s label was updated after the FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety Risk Management Advisory Committee, by a majority vote, recommended the removal of the boxed warning this September.
EAGLES is a randomized, double-blind, active, placebo-controlled study that evaluated neuropsychiatric safety of Chantix/Champix (Chantix’s trade name in the EU and other countries) and bupropion, compared to placebo and nicotine replacement therapy patch (NRT), in patients with or without a history of psychiatric disorder.
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 bupropion, nicotine patch or placebo.
Pfizer had submitted a supplemental New Drug Application (sNDA) to the FDA earlier this year, requesting for the inclusion of safety and efficacy data from the EAGLES study, and removal of the boxed warning.
In May 2016, Champix’s EU label was updated to include safety and efficacy data from the EAGLES study. Further, the black triangle symbol, which indicated the requirement of additional safety monitoring for Champix, was removed.
We note that the EAGLES study was conducted by Pfizer in collaboration with GlaxoSmithKline plc (GSK - Free Report) , in consultation with the FDA as well as the European Medicines Agency.
In the third quarter of 2016, Chantix/Champix generated sales of $198 million, up 24% year over year.
Pfizer carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Heska Corporation and Cambrex Corporation . Both these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates improved 19.5% for 2016 and 10.9% for 2017 over the last 60 days. The company posted a positive earnings surprise in each of the four trailing quarters, with an average beat of 301.64%. Its share price has increased 80.6% year to date.
Cambrex’s earnings estimates increased 4.1% for 2016 and 5.2% for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 19.78%. Its share price is up 15.3% year to date.
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Today, you are invited to download the full list of 220 Zacks Rank #1 ""Strong Buy"" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 ""Strong Sells"" and other private research. See these stocks free >>