I would like to encourage all of you to please copy and send the letter below to the FDA at druginfo@fda.hhs.gov
The CF community needs to get this drug approved by the FDA. We need your help to be heard loud and clear. Please sign your letter and include your city and state then ask all your family and friends to do the same.
If you are interested you can read the press release from Gilead the drug maker at www.gilead.com/pr_13646662
Thank you,
Lori
Co-Founder of the Living Breath Foundation
I am writing to you today about a product that is attempting to get FDA approval, Aztreonam Lysine for Inhalation. The product is manufactured by Gilead and will serve the purpose of fighting against Pseudomonas Aeruginosa infections in the airways of Cystic Fibrosis patients. It has already been approved in both Europe & Australia under the name Cayston(R) and the US has been lagging behind in its approval. Our Cystic Fibrosis patients with Pseudomonas Aeruginosa are running out of antibiotic options to help fight infections in their lungs. Effectively treating infections in patients with CF is very challenging, and new treatment options are urgently needed. This medicine offers some new hope in their battle to maintain the health of their lungs. About 60% of people with Cystic Fibrosis have a chronic respiratory infection caused by the bacteria called Pseudomonas Aeruginosa that settles into the thick mucus trapped in the airways. Once it sets up house in the respiratory tract, Pseudomonas Aeruginosa is almost impossible to get rid of. Respiratory failure caused by the infection is often the ultimate cause of death in many people suffering from Cystic Fibrosis. The FDA has established a target review date, under the Prescription Drug User Fee Act (PDUFA), of February 13, 2010. I would like to urge you to please grant this medicine the go ahead for approval. The FDA Advisory Committee vote 15-2 in favor of this medicine and 17-2 on the correct dose and regimen.
