Gilead Sciences has reported that FDA’s Anti-Infective Drugs Advisory Committee has recommended aztreonam for inhalation solution to be approved for the treatment of infections due to Pseudomonas aeruginosa (P. aeruginosa), in patients with cystic fibrosis (CF).
The committee voted 15 to 2 that Gilead has provided evidence of the safety and efficacy of aztreonam for inhalation solution. The panel also said that aztreonam for inhalation solution 75mg three times daily is a correct dose and regimen.
The company said that the recommendations of the Advisory Committee are not binding but will be considered by the FDA as the agency completes its review of Gilead’s application. The FDA has established a target review date, under the Prescription Drug User Fee Act (PDUFA), of February 13, 2010. In the interim, Gilead will continue to make the product available through its expanded access program in the US.
Reportedly, Gilead had originally submitted the NDA for the potential product in November 2007. In September 2009, the product was granted conditional marketing approval in Canada and the European Union under the trade name Cayston (aztreonam lysine 75mg powder and solvent for nebuliser solution). Applications for marketing approval of Cayston are also pending in Australia, Switzerland and Turkey.
Aztreonam for inhalation solution is an 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. Aztreonam formulated with arginine is an FDA-approved agent for intravenous administration for treating various infections.
Aztreonam formulated with lysine is a proprietary formulation of aztreonam developed specifically for inhalation. It has been designated with orphan drug status in the US and European Union, said the company.