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February 23rd, 2012 
FAKE NEWS for the Zionist agenda SILVER SPRING, Maryland (Reuters) – An experimental inhaled lung treatment from Forest Laboratories Inc and Almirall SA won a U.S. panel’s support on Thursday, a boost for the companies’ chances of eventually gaining approval for a drug to treat smoker’s cough.
A panel of outside expert advisers to the Food and Drug Administration voted 12-2 to recommend approval of the twice-daily drug, known generically as aclidinium bromide.
The drug treats chronic obstructive pulmonary disease, commonly called smoker’s cough as it is often caused by cigarette smoking. It is the fourth-leading killer of Americans.
However, panelists called for the company to do post-approval studies to test safety, as some patients died from heart problems during clinical trials.
“I think the efficacy is modest, but with COPD treatments, the efficacy tends to be modest,” said panel member Dr. William Calhoun, professor at the University of Texas Medical Branch.
“It seems to me that the critical question here is the safety issue.”
The FDA usually follows panel recommendations, although it is not required to, and a final decision is expected by April 23.
Shares of Forest, which has a licensing agreement with the Spanish drugmaker Almirall to market the drug in the United States, rose 1 percent to $32.17 in late afternoon trading on the New York Stock Exchange.
Forest is counting on new treatments such as aclidinium to help prop up profits after the top product it markets in the United States, the antidepressant Lexapro, is expected to lose U.S. patent protection this year.
Wall Street expects global sales of COPD treatments to exceed $5 billion in 2014.
FDA staff reviewers earlier this week raised concerns about potential heart problems linked to drugs in the same class. They said clinical trials may not have been big enough to show whether the problems came from the drug, or because patients with COPD often have heart issues.
(Reporting by Anna Yukhananov; Editing by Gary Hill)
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