Shares in Gilead Sciences fell 2.4 % to $44.05 in afternoon trading on March 19, after the US drugmaker's cystic fibrosis drug aztreonam lysine was rejected by the European Medicine Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).
The CHMP adopted a negative opinion on the company's Marketing Authorization Application for the 75mg powder and solvent for nebulizer solution of aztreonam lysine, which is an investigational therapy in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection.
"We are disappointed by the Committee's opinion, but remain committed to advancing therapies for patients with cystic fibrosis," said Norbert Bischofberger, Gilead's chief scientific officer. "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," he added.
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