Will fourth action letter be the charm for Discovery’s Surfaxin?
This article was originally published in Pharmaceutical Approvals Monthly
The fourth review cycle for its Surfaxin (lucinactant) NDA with a fourth action letter, Discovery Labs announces April 20. FDA's primary issue in the latest complete response letter centers on whether a biological activity test used for quality control, stability and release testing "can adequately distinguish change of Surfaxin drug product over time," CEO Robert Capetola told an April 20 teleconference to discuss the NDA for the synthetic surfactant for prevention of respiratory distress syndrome in premature infants. "The data to address these issues with FDA on this BAT already reside with the FDA," Capetola said. The company's response to the third action letter included preclinical studies related to the BAT, Discovery noted last autumn (1Pharmaceutical Approvals Monthly October 2008, In Brief). "We're going to request an end-of-review meeting with the FDA to take place as soon as possible," Capetola said. He noted that the necessary data, "submitted through multiple NDA filings over the years," could be "somewhat fragmented." The CEO stressed that the company must "represent the existing information in front of FDA in a way that clearly defines the capabilities of the BAT as we described it and documented it for them.
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Discovery Laboratories now believes March 2012 could mark the end of an almost eight-year regulatory odyssey to secure FDA approval of its synthetic surfactant Surfaxin (lucinactant).
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
Discovery Labs says the response to a May 2008 approvable letter for its neonatal respiratory distress syndrome therapy Surfaxin could be designated as a Class 1 resubmission, resulting in a 60-day review period and a mid-December PDUFA target date, the firm says Oct. 17. In September, Discovery announced technical success at addressing the outstanding requirements identified in the third approvable letter for Surfaxin (lucinactant), including completing pre-clinical studies in a biological activity test and satisfying International Conference on Harmonization guidelines for lipid-related impurities in active pharmaceutical ingredients (1Pharmaceutical Approvals Monthly August 2008, In Brief). Labeling discussions and a manufacturing inspection have been successfully completed