An FDA advisory panel voted 14-1 on Wednesday to recommend that the agency withdraw its approval of the drug Makena, saying the treatment does not appear to reduce the risk of preterm birth.
A final decision is now up to agency regulators, who are widely expected to agree — having proposed to reverse the agency’s approval of the drug two years ago.
That proposal was challenged by drug maker Covis Pharma, which is based in Luxembourg and has U.S. offices in King of Prussia, Pennsylvania. The FDA approved the drug for sale in 2011 after an accelerated review process, given that there were few effective treatments for preventing premature birth.
