The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead’s Marketing Authorisation Application for aztreonam lysine 75mg powder and solvent for nebuliser solution (aztreonam lysine). They are intended for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF), aged 18 years and older.
The opinion is for conditional approval, contingent on the successful completion of an ongoing study.
CHMP’s positive recommendation will be reviewed by the European Commission. Gilead expects the European Commission to issue its decision on the marketing authorization for aztreonam lysine later this year.
The company has also submitted applications for marketing approval of aztreonam lysine in Australia, Canada, Switzerland and Turkey.
Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences, said: “We are pleased that the CHMP has recognized the potential therapeutic benefit of aztreonam lysine in addressing chronic pseudomonal airway infection. We look forward to delivering this new therapeutic option to patients in the European Union as quickly as possible.”