Aztreonam Approved!!!!

I know several of you actually participated in studies of this drug. I actually was in the study as well, but discontinued it due to side effects. However, on Monday, the FDA approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) for the treatment of CF. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including an early $1 million investment to help develop the therapy. The approval of Cayston demonstrates that our drug development model, fueled by donors and volunteers like you, is working and making a real difference in the lives of people with cystic fibrosis.

Developed by Gilead Sciences, Inc., Cayston offers a much-needed antibiotic alternative for CF patients who battle recurrent lung infections and develop resistance to existing antibiotics. Cayston is used in a 1 month on, 1 month off cycle, similar to TOBI. Cayston is administered with a new device called Altera that allows patients to take the medicine in less than five minutes, a fraction of the time required for other inhaled antibiotics. This shortened delivery time reduces the burden on patients, who -- on average -- have a treatment regimen of three to four hours per day.

“The Cystic Fibrosis Foundation’s early funding and ongoing support for Cayston played an important role in bringing this new therapy to patients,” said Bruce Montgomery, M.D., senior vice president, head of Respiratory Therapeutics, Gilead Sciences. “We are thrilled to help meet an urgent medical need for CF patients, and to support the Foundation’s mission to improve the lives of people with this terrible disease.”

Cayston will be available by the end of next week. Patients interested in learning more about Cayston should consult their physicians. You can also visit their website for more information. Also, attached here is an official drug information sheet for patients.

The Cayston Access Program assists with reimbursement and access to Cayston. The Cayston Access Program reimbursement specialists can answer questions related to insurance coverage, financial assistance, specialty pharmacy referral, and claims appeal support. Attached here is a brochure with more reimbursement information.