FDA Approves First New Inhaled Antibiotic For CF In More Than A Decade

Main Category: Cystic Fibrosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Feb 2010 - 5:00 PDT

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The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

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. Lung infections are the leading cause of death in CF.

Cayston is the first CF drug to advance - from beginning to end - through the Cystic Fibrosis Foundation's Therapeutics Development Program, which is designed to speed the creation of new CF therapies. In addition, Cystic Fibrosis Services, Inc, a wholly owned subsidiary of the Foundation, will be one of only several pharmacies in the country distributing the drug.

Cayston will be available by the end of next week.

"The approval of Cayston demonstrates that our drug development model is working and making a real difference in the lives of people with cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "We are delighted to have a new antibiotic in the arsenal to help fight the life-threatening infections associated with this disease, as we continue to push forward with other therapies that address the underlying cause of CF."

The Foundation supported Cayston at each stage of development, from providing an initial therapeutics development award, to making the Foundation's clinical trials network available to test the drug in patients, to advocating with the FDA for the drug's approval.

"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 is administered with a new device called the Altera(R) Nebulizer System 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.

Patients interested in learning more about Cayston should consult their physicians.

To support patients, Gilead is launching a Cayston Access Program, a call center developed with a nonprofit subsidiary of the Cystic Fibrosis Foundation. The program will assist people with CF and members of their care team with insurance verification, co-pay assistance and claims support.

In 2004 Cystic Fibrosis Foundation Therapeutics, Inc., a nonprofit affiliate of the Cystic Fibrosis Foundation, gave a therapeutics development award to Corus Pharma to support an experimental drug now known as Cayston. In 2006, Gilead Sciences acquired Corus and continued the program, filing a New Drug Application with the FDA in 2007.

Source
Cystic Fibrosis Foundation

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