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Will March 2012 Mark The End Of Regulatory Limbo For Discovery’s Surfaxin?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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).

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Will fourth action letter be the charm for Discovery’s Surfaxin?

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.

Synthekine Joins Quest To Tame IL-2 In Cancer Therapies

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