Gilead Sciences, a biotechnology company, has announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a negative opinion on the company’s marketing authorization application for aztreonam lysine 75mg powder and solvent for nebuliser solution in the EU.
Gilead said that it will confer with European regulatory bodies to determine appropriate options to address the issues outlined in the Committee for Medicinal Products for Human Use (CHMP) opinion.
In the US, the FDA has informed Gilead of the need to conduct an additional clinical study before the company can resubmit its new drug application. Gilead has two ongoing clinical studies evaluating aztreonam for inhalation solution.
Aztreonam lysine is an investigational therapy in development for people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa infection. It has been designated with orphan drug status in the United States and Europe.
Norbert Bischofberger, chief scientific officer of Gilead Sciences, said: We are disappointed by the committee’s opinion, but remain committed to advancing therapies for patients with cystic fibrosis.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide.