Pfizer's hopes for Chantix up in smoke?
- The U.S. Food and Drug Administration convened a joint panel of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) on Wednesday to review a potential label change for Pfizer's quit-smoking drug Chantix (varenicline).
- Approved originally in 2006, Chantix currently has a black box warning — the most severe a drug can contain — warning about potential neuropsychiatric effects.
- The black box warning was put on the label after post-marketing reports started piling up from patients. The FDA pushed Pfizer to conduct an 8,000-patient post-marketing study to better understand the problem.
Now that results are in from Pfizer's study of the effects of Chantix in a real-world setting, the regulatory agency has come back to review its decision on the warning.
The big pharma argues the warning on the label is a deterrent to use and limits market potential, even though the post-marketing study showed there may not be an increased risk. But critics of the drug, including the advocacy group Public Citizen, say the study is inadequate to remove the warning and that patients have the right to know the risks.
The FDA is not required to abide by the advice of its panels and typically conducts them more as a feedback gathering tool. Even so, the regulatory agency often follows their recommendations.
In May 2016, Pfizer used data from the EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) trial to sway the EU and have the European Medicines Agency remove the Black Triangle warning that the drug carried there.
Total revenues for the drug worldwide for the first half of the year were $434 million, up 31% from the year-prior.
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