FDA to Give Pfizer Drug Priority Review

By Anthony Cronin, The Day, New London, Conn.

Dec. 22–Pfizer Inc. said Wednesday that federal drug regulators have agreed to a priority review of its much-anticipated smoking-cessation drug that has caught the attention of industry analysts and anti-smoking advocates.

The New York-based Pfizer, which employs about 6,000 at its campuses in Groton and New London, said the federal Food and Drug Administration has granted a six-month priority review of the drug maker’s new drug application for varenicline.

Pfizer filed the smoking cessation drug with U.S. and European regulators in November.

Pfizer said it plans to call the new drug Champix. The FDA agrees to priority review status on new drug applications if it believes the new medication could provide a significant therapeutic advance over existing drugs.

Shares of Pfizer, which trade on the New York Stock Exchange, were little affected by the news about the expedited review by federal regulators. The stock closed the day’s trading at $24.04 a share, up 4 cents from the prior day’s closing price. The company’s stock volume, representing the number of shares bought or sold, was relatively light.

Pfizer officials have said the World Health Organization estimates that a person dies every eight seconds of a smoking-related disease. Less than 7 percent of smokers who try to quit on their own can stay cigarette-free for more than one year, according to Pfizer officials.

Hank McKinnell, Pfizer’s chairman and chief executive officer, said if current smoking demographics continue, the number of people dying from smoking-related diseases will double from 5 million to 10 million by 2020. In its clinical trials, which are required before a drug can seek formal approval from federal regulators, varenicline was well tolerated in the test patients. The most common side effects included nausea, headache, sleeping trouble and abnormal dreams.

Pfizer researchers said that when a smoker inhales a cigarette, nicotine reaches the brain within seconds and binds to a nicotine receptor that activates a “reward pathway” in the brain. That reaction creates a powerful form of satisfaction, but a cycle of craving and withdrawal soon follows.

Karen Katen, Pfizer’s vice chairman and president of its human health division, said smoking is the leading cause of preventable death worldwide. She said the cost of treating smoking-related diseases in this country alone reaches about $150 billion a year.

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