Navigation Links
FDA Approves First New Inhaled Antibiotic for CF in More Than a Decade
Date:2/22/2010

CF Foundation's $1 Million Investment Helped Drug Known as Cayston(R) Become a Reality

BETHESDA, Md., Feb. 22 /PRNewswire-USNewswire/ -- 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. For information, call 1-877-7CAYSTON (877-722-9786).

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.  

About the Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation is the world's leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. For more information, please visit www.cff.org.

SOURCE Cystic Fibrosis Foundation

Back to top

RELATED LINKS
http://www.cff.org

'/>"/>

SOURCE Cystic Fibrosis Foundation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinsons Disease
2. FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
3. FDA Approves Xiaflex for Debilitating Hand Condition
4. FDA Approves Once-A-Day Lamictal(R)XR(TM) as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures
5. Chinese State Food and Drug Administration Approves Company Facility for Producing Solid Dosage Perindopril
6. FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
7. FDA Approves a High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older
8. FDA Approves Lillys ZYPREXA(R) RELPREVV(TM) for Treatment of Schizophrenia in Adults
9. FDA Approves Lillys Zyprexa for Two Adolescent Indications
10. US FDA Approves SEROQUEL XR(R) For Add-On Treatment of Major Depressive Disorder
11. FDA Approves Use of Roche Test to Screen Source Plasma for HIV, Hepatitis B Virus and Hepatitis C Virus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):