Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=aYFsIoFmXyPw
Glaxo Shares Fall After FDA Finds Asthma Drug Risk
By Molly Peterson
Feb. 19 (Bloomberg) -- GlaxoSmithKline Plc declined in London trading after U.S. regulators warned against long-term use of the company’s best-selling product, the Advair asthma treatment, and called for further study of potential health risks.
Advair and AstraZeneca Plc’s Symbicort combine drugs from a class known as long-acting beta agonists with inhaled corticosteroids. The agonists have been linked to increased risk of worsening asthma symptoms, hospitalizations and deaths, the Food and Drug Administration said yesterday. Use should stop once symptoms are under control, the agency said. The warning may curb U.S. sales of the medicines and hamper development of a new compound for lung disease Glaxo is working on with Theravance Inc., said Mark Purcell and Brian Bourdot of Barclays Capital.
“The FDA language may be ambiguous, but the intent seems clear,” Purcell and Bourdot wrote in a note to clients today. It appears “the FDA would like to see LABA use come down.”
The agency advised against using products containing long- acting beta agonists alone. An outside panel will meet next month to gather information on how to design studies for the combination drugs, the FDA said in a statement.