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 negative opinion on the company's Marketing Authorisation Application (MAA) for aztreonam lysine 75 mg powder and solvent for nebuliser solution (aztreonam lysine) in the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection.
"We are disappointed by the Committee's opinion, but remain committed to advancing therapies for patients with cystic fibrosis," said Norbert Bischofberger, executive vice president, Research and Development and chief scientific officer, Gilead Sciences. "Chronic pseudomonal airway infection is the leading cause of morbidity and mortality among people living with cystic fibrosis, and with a limited number of treatment choices, there remains a significant unmet medical need."
Gilead will confer with European regulatory bodies to determine appropriate options to address the issues outlined in the CHMP opinion. 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 aztreonam for inhalation solution.
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 has potent in vitro activity against Gram-negative bacteria such as P. aeruginosa.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.