Discovery Laboratories Inc. won approval for its treatment to prevent respiratory distress in high-risk premature infants on its fifth try to get the drug on the market. The shares gained in late trading.
The Food and Drug Administration cleared the Warrington, Pennsylvania-based company’s leading product, Discovery Laboratories said in a statement today. The company said it expects the drug, Surfaxin, will be commercially available in the U.S. in late 2012.
Discovery Labs first filed for approval in 2004 and was most recently rejected in 2009. The FDA said the company couldn’t verify that Surfaxin used in clinical trials worked the same as the commercial version according to a statement from Discovery Labs.
“This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care,” W. Thomas Amick, chairman of the board and chief executive officer of Discovery Labs, said in the statement.
When the agency previously rejected the drug, the FDA disagreed with Discovery Labs method for testing the quality and stability of Surfaxin in clinical trials and asked them to use the agency’s preferred method on the currently manufactured drug, Michael Parks, a spokesman, said in a telephone interview. The agency said Discovery Labs responded to regulators’ concerns in September.
Discovery Laboratories jumped 33 percent to $5 at 4:41 p.m New York time in extended trading after U.S. markets closed.
The medicine will compete with Abbott Park, Illinois-based Abbott Laboratories’ Survanta.
Respiratory distress in infants whose lungs haven’t fully developed is caused in part by the lack of a substance called surfactant that helps the lungs inflate with air, according to the National Institutes of Health in Bethesda, Maryland. Most cases of the potentially fatal condition are in babies born before 28 weeks of a 40-week term. Surfaxin is a synthetic version of the substance.
More than 500,000 babies are born premature, or before 37 weeks, each year, according to the March of Dimes, a White Plains, New York-based charity. About 10 percent are born between 28 and 31 weeks of gestation.
Surfaxin did not significantly differ from Abbott’s Survanta at reducing respiratory distress 24 hours after birth, though it did reduce mortality rates at 14 days of life compared to the Abbott drug, according to a clinical trial published in a 2005 edition of the journal Pediatrics.