Gilead Sciences, Inc announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorisation Application for aztreonam lysine 75 mg powder and solvent for nebuliser solution (aztreonam lysine) 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.
The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the European Union. Gilead expects the European Commission to issue its decision on the marketing authorization for aztreonam lysine later this year. Aztreonam lysine was previously reviewed by the CHMP in March and received a negative opinion, which Gilead appealed.
"We are pleased that the CHMP has recognized the potential therapeutic benefit of aztreonam lysine in addressing chronic pseudomonal airway infection - the single greatest cause of morbidity and mortality for people with cystic fibrosis," said Norbert Bischofberger, executive vice president, Research and Development and chief scientific officer, Gilead Sciences. "We look forward to delivering this new therapeutic option to patients in the European Union as quickly as possible."
Gilead has also submitted applications for marketing approval of aztreonam lysine in Australia, Canada, Switzerland and Turkey. In the United States, the US. Food and Drug Administration (FDA) has informed Gilead of the need to conduct an additional clinical study before the company can resubmit its New Drug Application. Gilead has two ongoing clinical studies evaluating the product among patients with CF.
Aztreonam lysine 75 mg powder and solvent for nebuliser solution is an inhaled antibiotic candidate for people with cystic fibrosis who have P. aeruginosa. Aztreonam formulated with arginine (Azactam) is an approved agent for intravenous administration for treating various infections.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.