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news.Gilead Sciences, a biopharmaceutical company, has received a complete response letter from the FDA for its new drug application for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa.
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In this letter, the FDA informed Gilead that the review of the company’s new drug application (NDA) has been completed. The agency stated that they cannot approve the application in its current form and an additional clinical study will be required.
Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter.
Marketing applications for aztreonam lysine for inhalation are under review by regulatory agencies in the EU, Australia, Switzerland, Turkey and Canada.
John Martin, chairman and CEO of Gilead, said: “Our goal is to work with the FDA to deliver this product to the medical community and to people living with cystic fibrosis as quickly as possible. The FDA has not raised any significant concerns regarding the safety profile of aztreonam lysine. Therefore, we will continue our expanded access program for those individuals who have limited treatment options and are at risk of disease progression.”