FDA Advisory Committee Recommends Withdrawal of AMAG’s Preterm Birth Drug

November 7, 2019

An FDA advisory committee voted to support withdrawal of FDA approval for AMAG Pharmaceuticals’ preterm birth injection Makena (hydroxyprogesterone caproate).

Nine members of the panel voted for the agency to seek withdrawal of approval, while seven voted to keep Makena on the market while requiring a new clinical trial.

Makena is the only FDA approved drug for preventing preterm birth in women who are pregnant with one child and have a history of preterm births. When the drug was granted accelerated approval in 2011, the agency required a confirmatory trial to verify the drug’s benefit.

But the results were disappointing as they did not show a statically significant difference between the treatment and placebo and didn’t demonstrate that the drug reduced the rate of fetal and neonatal health problems or death.

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