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Gilead Moves Closer to US Approval of CF Treatment

From Associated Press (December 10, 2009)

FOSTER CITY, Calif._Gilead Sciences Inc. said Thursday an advisory committee has recommended U.S. approval of the biotechnology company's inhalable cystic fibrosis treatment candidate.

The company said the Anti-Infective Drugs Advisory Committee of the Food and Drug Administration recommended that aztreonam be approved. The drug is aimed at treating chronic lung infections caused by the bacterium Pseudomonas aeruginosa. Gilead has said those lung infections are the biggest killer of people with cystic fibrosis.

The FDA is not required to follow the recommendation of its advisory committees, though it normally does. The FDA set a target review date of Feb. 13 for the drug candidate.

The drug is already conditionally approved in Canada and the European Union under the trade name Cayston.

Shares of Gilead rose 4 cents to $46.33 in after-hours trading after rising 29 cents to close at $46.29 during the regular trading session.


Posted: December 2009