The European Commission has granted a conditional marketing authorisation to Cayston (aztreonam lysine) for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF).
The Cayston 75mg powder and solvent for nebuliser solution (aztreonam lysine) has been approved for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in CF patients aged 18 years and older.
The drug will be made available from early 2010, subject to the requirements of national authorities.
CF is a debilitating genetic disease that affects 35,000 people in the European Union. Chronic pulmonary infections due to P. aeruginosa are the single greatest cause of morbidity and mortality among patients with CF.
Cayston is an inhaled antibiotic that is delivered via the Altera Nebuliser System, a drug-specific delivery device from the eFlow Technology Platform developed by PARI Pharma GmbH. PARI Pharma also contributed to the development of Cayston’s drug formulation for delivery with the Altera Nebuliser System.
“Cayston is an important addition to the fight against infection in people with cystic fibrosis, and its approval will bring a further treatment option to patients suffering from this debilitating disease,” said Stuart Elborn, Professor of Respiratory Medicine, Queens University of Belfast. “The cystic fibrosis community is very pleased that the EMEA has recognised the importance of bringing forward this effective new treatment.”
Full marketing authorisation will be based on the results of an ongoing Phase III study examining the efficacy and safety of Cayston compared to tobramycin nebuliser solution in CF patients with pulmonary P. aeruginosa.