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Discovery Labs gets second approvable letter for Surfaxin
By Elaine Rigoli
Tampa, Fla., April 5 - Discovery Laboratories, Inc. has received a second approvable letter from the Food and Drug Administration for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants.
The approvable letter is an official notification from the FDA and contains conditions that Discovery must satisfy prior to obtaining final U.S. marketing approval.
Specifically, the FDA is requesting certain information primarily focused on the chemistry, manufacturing and controls section of the New Drug Application, according to a news release.
The information predominately involves the further tightening of active ingredient and drug product specifications and related controls, the release said.
RDS is a life-threatening and costly breathing disorder that strikes tens of thousands of premature infants in the United States each year, with a global at-risk population in excess of 500,000 infants.
About 75,000 infants are treated with surfactants in the United States annually. Current surfactant treatment options are limited to animal-derived surfactants harvested from cows and pigs, the release said.
Surfaxin, a peptide-containing, synthetic surfactant, is designed to mimic the function of natural human lung surfactant and represents a potential alternative to animal-derived surfactants.
Discovery said its earlier study demonstrated that Surfaxin was significantly more effective in the prevention of RDS and improved survival and other outcomes versus comparator surfactants.
This is the second approvable letter from the FDA since the company's NDA for Surfaxin was filed in April 2004. The company's previously submitted responses to the first approvable letter were accepted by the FDA as a complete response in October 2005.
Discovery Laboratories is a biotechnology company based in Warrington, Pa.
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