Gilead Sciences has been told that it needs to conduct an additional clinical study before resubmitting an application for its new cystic fibrosis drug.
The 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 authorisation 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.
Norbert Bischofberger, chief scientific officer of Gilead Sciences, said that "Gilead was disappointed by the committee's opinion, but remained committed to advancing therapies for patients with cystic fibrosis".
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 US and Europe.
By Daniel Garrun.