Consumer Drug Report
FDA finally approves Surfaxin®

On March 6, 2012, the Food and Drug Administration (FDA) approved Surfaxin to treat respiratory distress syndrome (RDS). RDS is a potentially dangerous condition that occurs when an infant is incapable of naturally producing pulmonary surfactant, a liquid coating inside the lungs that helps to keep them open. Premature infants may show signs of RDS at birth or within the first few hours after delivery.

Biopharmaceutical company Discovery Laboratories Inc. develops surfactant technology for surfactant replacement therapies (SRT) to treat various respiratory diseases. The company filed for a new drug application in 2004. Since then, Discovery Laboratories has been denied marketing permission four times. In 2005, an “approvable letter” was sent stating that the new drug application will be reviewed and included specific terms and conditions that must be met prior to gaining U.S. marketing permission.  

In 2009, the FDA asked Discovery to validate a biological activity test (BAT) to ensure Surfaxin’s quality and stability.  A number of meetings were scheduled with Discovery to discuss details of the BAT and to establish a plan for moving forward before Surfaxin could be commercially marketed in the United States.

Last month, an Advisory Panel for the FDA recommended that Surfaxin be approved. Surfaxin is the fifth drug to be approved in the U.S. for RDS treatment. It is the first synthetic peptide containing surfactant to be approved for commercial use in neonatal medicine. It is estimated that 90,000 premature infants receive animal deprived surfactant treatments each year in the U.S. 

Moving forward

Discovery Laboratories states that commercial marketing of Surfaxin will take place later this year. The company anticipates sales to range between $50 million and $75 million. It also plans to conduct clinical programs for acute respiratory distress syndrome (ARDS) in adults, neonatal respiratory disorders (NRD) in infants, severe asthma in adults, and other respiratory diseases.


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