Discovery Laboratories, Inc, announced that the US Food and Drug Administration (FDA) has accepted for review Discovery Labs' Complete Response for Surfaxin (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The FDA has designated the Complete Response as a Class 2 resubmission and has established April 17, 2009 as its target action date under the Prescription Drug User Fee Act (PDUFA) to complete its review and potentially grant marketing approval for Surfaxin.
The Complete Response addressed all of the remaining requirements contained in the May 2008 Approvable Letter that must be satisfied to gain US marketing approval for Surfaxin. Discovery Labs provided the FDA specific data, information and minor clarifying analyses and believes that its Complete Response supports the approval of Surfaxin.
The May 2008 Approvable Letter did not require any additional clinical trials. Prior to receiving the Approvable Letter, Discovery Labs made notable progress towards gaining FDA approval of Surfaxin, including agreeing with the FDA on the content of the Surfaxin package insert and successfully concluding a pre-approval inspection of Discovery Labs' manufacturing operations.
Surfaxin represents the first peptide-containing, synthetic surfactant potentially available for addressing RDS. RDS is a condition in which premature infants are born with an insufficient amount of their own natural surfactant, a substance produced naturally in the lungs and essential for breathing. This condition often requires that infants receive surfactant replacement therapy (currently animal-derived surfactants) along with mechanical ventilation to survive. More than 500,000 infants born each year are at risk for developing RDS in the developed world. In the United States, RDS afflicts approximately 120,000 premature infants annually, of which approximately 80,000 of those infants are treated with the currently-available surfactants.
Discovery Laboratories is a biotechnology company developing Surfactant Replacement Therapies (SRT) for respiratory diseases.