Discovery finds path for Surfaxin approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
After meeting with FDA on Sept. 29, Discovery Labs has agreed with the agency on an approach to resolving the remaining primary issue standing in the way of approval of its Surfaxin (lucinactant), a surfactant for prevention of Respiratory Distress Syndrome in premature infants. Discovery received a "complete response" letter on the application April 17; it was the fourth action letter on the application (1Pharmaceutical Approvals Monthly April 2009). The firm has identified a new program for optimization and final method validation of its fetal rabbit Biological Activity Test (a quality control and stability release test that can distinguish change in Surfaxin biological activity over time) and a proposed "limited Surfaxin clinical trial design," which would employ the new BAT. The additional trial would primarily assess pharmacodynamic response following Surfaxin administration in preterm infants, the company explained. The final design will be submitted to FDA for review mid-fourth quarter 2009