experimental smoking cessation drug
experimental smoking cessation drug
Reuters.co.in: "NEW YORK (Reuters) - Pfizer Inc. said on Wednesday that U.S. regulators have granted a priority review to its experimental smoking cessation drug.
Under a priority review, the U.S. Food and Drug Administration will make its decision whether to approve the drug within six months, rather than the usual 10- to 12-month review period.
The world's largest drugmaker said it plans to market the drug, varenicline tartrate, under the brand name Champix if it is approved.
The FDA assigns priority review status to medicines that may provide a significant therapeutic advance over existing therapies.
According to data from a late-stage clinical trials released last month, varenicline was more effective than GlaxoSmithKline Plc's Zyban at helping smokers to quit.
In the 12-week studies, 44 percent of smokers who used varenicline were able to quit the habit compared with 30 percent among those using Zyban, also known by the chemical name bupropion.
However, the sustained ability to kick the habit was far less pronounced between the two drugs once smokers had stopped taking the medication.
'If current smoking patterns continue, the annual number of people dying of smoking-related diseases globally will double from five to 10 million deaths by 2020,' said Pfizer Chief Executive Hank McKinnell in a statement.
Pfizer shares were up 24 cents, or 1 percent, to $24.24 on the New York Stock Exchange."
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