Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the European Commission has granted conditional marketing authorization for Cayston® 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF) aged 18 years and older. Cayston will be made available in certain countries of the European Union, subject to the requirements of national authorities, beginning in early 2010.
CF is a chronic, debilitating genetic disease that affects the respiratory and digestive systems of approximately 70,000 people worldwide, including 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 dosed three times per day over a 28-day period. Cayston 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 recognized the importance of bringing forward this effective new treatment.”