FDA Advisory Committee Supports Use Of Aztreonam For Inhalation Solution For Patients With Cystic Fibrosis

Main Category: Cystic Fibrosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Dec 2009 - 0:00 PDT

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Gilead Sciences, Inc. (Nasdaq: GILD) announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended that aztreonam for inhalation solution 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 sufficient evidence of the safety and efficacy of aztreonam for inhalation solution. The panel also voted 17 to 0 that aztreonam for inhalation solution 75 mg three times daily is a correct dose and regimen.

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 United States.

"Effectively treating infections in patients with CF is very challenging, and new treatment options are urgently needed," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "We will continue to work closely with the FDA as it completes its review of aztreonam for inhalation solution."

CF is a chronic, debilitating genetic disease that affects the respiratory and digestive systems of approximately 70,000 people worldwide. Chronic pulmonary infections due to P. aeruginosa are the single greatest cause of morbidity and mortality among patients with CF.

Gilead 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 75 mg powder and solvent for nebuliser solution). Applications for marketing approval of Cayston are also pending in Australia, Switzerland and Turkey.

About Aztreonam for Inhalation Solution

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 United States and European Union.

In the United States, aztreonam for inhalation solution has not yet been determined by the FDA to be safe or efficacious in humans for its ultimate intended use.

Source
Gilead Sciences

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