When was cayston approved

Cayston must not be used in people who are hypersensitive allergic to aztreonam or any of the other ingredients. The CHMP concluded that there was an unmet medical need for new antibiotics in patients with cystic fibrosis, since many of these patients have already developed resistance to other antibiotics by the time they reach adulthood, and because P.

The European Commission granted a marketing authorisation valid throughout the European Union for Cayston on 21 September For more information about treatment with Cayston, read the package leaflet also part of the EPAR or contact your doctor or pharmacist. More detail is available in the summary of product characteristics. Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis CF aged 6 years and older.

Consideration should be given to official guidance on the appropriate use of antibacterial agents. This product is no longer an orphan medicine. Cayston was withdrawn from the Community register of orphan medicinal products in September at the end of the year period of market exclusivity.

Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.

Cayston RSS. Table of contents Overview Authorisation details Product information Assessment history. Expand section Collapse section. The medicine can only be obtained with a prescription.

The additional study produced results that were consistent with those of the main studies. Doses should be taken at least 4 hours apart. Adverse events associated with the use of Cayston may include, but are not limited to, the following:. The FDA approval of Cayston was based on a randomized, double-blind, placebo-controlled, multicenter trial in subjects. The subjects received either Cayston 75 mg or volume-matched placebo administered by inhalation 3 times a day for 28 days.

Patients were required to have been off antibiotics for at least 28 days before treatment with study drug. About the Cystic Fibrosis Foundation The Cystic Fibrosis Foundation is the world's leader in the search for a cure for cystic fibrosis.

Media Contact Laurie Fink, director of media relations: ; lfink cff. Share this article. You might also be interested in Stay up to date with The Foundation. While the markets may not have been excited the approval will be gratefully received by the CF community, which is desperate for new treatments. Gilead is wasting no time meeting any new demand, forging ahead with plans to launch the drug by the end of next week. Also as a new therapy option take up of Cayston should be good, despite it going up against Novartis' TOBI, which has pretty much had little competition since it launched in December Gilead is also increasing its chances of taking more sales from the Novartis drug by launching head-to-head trials.

The results, which are due in the middle of this year, will determine just how much switching will go on. As such the group will be hoping that two of the phase III candidates that it inherited from the purchase: Adentri, a drug for heart failure and CVT, an arrhythmia drug, will like Cayston eventually make it through to approval.

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