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
