EMEA panel recommends against Gilead CF drug

Yet another setback for Gilead Sciences' cystic fibrosis treatment candidate aztreonam lysine--a treatment designed to fight off bacterial infection in airways of cystic fibrosis patients. A European Medicines Agency advisory committee has recommended against the approval of the inhalable treatment, the Gilead announced on Thursday. Of course, with a the negative recommendation from the advisory panel, it's likely the EMEA will also reject the drug. 

"We are disappointed by the Committee's opinion, but remain committed to advancing therapies for patients with cystic fibrosis," said Norbert Bischofberger, PhD, 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."

Last September, the FDA told Gilead it would need an additional study before it could make a decision. The company is currently conducting two studies.

- check out the Gilead release

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