Gilead Cystic Fibrosis Drug Faces Hurdle in Europe
Fri, 03/20/2009 - 6:37am
FOSTER CITY, Calif. (AP) — Biotechnology company Gilead Sciences Inc. said Thursday a European advisory committee recommended against approving the company's inhalable cystic fibrosis treatment candidate. The company is trying to gain approval for aztreonam lysine, which is designed to fight off bacterial infection in the airways of cystic fibrosis patients. In the U.S., the Food and Drug Administration has told Gilead it needs to conduct an additional study before it can again ask for regulatory approval. The company has two ongoing studies. The negative recommendation by the European Medicines Agency's Committee for Human Medicinal Products, or CHMP, will be taken into account by the European Commission when reviewing the application for approval. Like its U.S. counterpart, the European Commission generally follows the opinion of its advisers, though it is not obligated. "We are disappointed by the committee's opinion, but remain committed to advancing therapies for patients with cystic fibrosis," said Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead.