Gilead seeks EU marketing nod for nebuliser solution

Gilead Sciences, Inc. has submitted a Marketing Authorisation Application (MAA) for approval of aztreonam lysine 75 mg powder for nebuliser solution (aztreonam lysine) in the European Union. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the European Medicines Agency (EMEA).

Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalised, provides one marketing authorization in all member states of the European Union. Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis (CF) who have pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. Aztreonam lysine 75 mg powder for nebuliser solution is administered using an eFlow Nebuliser (PARI GmbH).

The MAA is supported by data from two phase III clinical studies (AIR-CF1 and AIR-CF2) and interim data from an ongoing open-label extension study (AIR-CF3) of patients who participated in AIR-CF1 or AIR-CF2.

"Chronic pseudomonal airway infection represents the single greatest cause of morbidity and mortality for people with cystic fibrosis, and with a limited number of inhaled antibiotics, there remains a significant unmet medical need," said A. Bruce Montgomery, MD, senior vice president and Head, Respiratory Therapeutics, Gilead Sciences. "The submission of this MAA in the European Union further underscores Gilead's commitment to advancing therapies for patients with this life-threatening disease."

Aztreonam lysine 75 mg powder for nebuliser solution is an investigational therapy and has not yet been determined safe or efficacious in humans. Aztreonam lysine 75 mg powder for nebuliser solution is an antibiotic candidate currently being studied in an ongoing phase III open label trial for people with cystic fibrosis who have pulmonary P. aeruginosa. Aztreonam has potent activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is a US Food and Drug Administration (FDA)-approved agent for intravenous administration. Aztreonam lysine is a proprietary formulation of aztreonam developed specifically for inhalation and has been designated with orphan drug status in the United States and Europe. In the United States, the investigational product is referred to as aztreonam lysine for inhalation. Gilead submitted its US New Drug Application for aztreonam lysine for inhalation to the FDA on November 16, 2007. The FDA has established a target review date, under the Prescription Drug User Fee Act, of September 16, 2008. Gilead submitted its application in Australia on November 30, 2007.

Aztreonam lysine 75 mg powder for nebuliser solution is delivered by an eFlow Nebuliser, developed by PARI Pharma GmbH. eFlow is a portable nebuliser that enables aerosolisation of liquid medications via a vibrating, perforated membrane. PARI Pharma also contributed to the development and optimization of the drug formulation (aztreonam lysine 75 mg powder for nebuliser solution) for delivery via eFlow. Based on PARI's 100-year history working with aerosols, PARI Pharma is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.