Public Citizen filed the petition after a followup study in March showed Makena is no more effective in preventing preterm birth than a placebo. The group said the FDA shouldn’t have approved Makena in 2011 under the accelerated approval program because data from a Phase 3 trial was “seriously flawed.” The advocacy group is also asking the FDA to prevent compounding pharmacies from supplying the drug.
The citizen’s petition notes that FDA reviewers raised serious concerns and identified major deficiencies in the initial application for the drug.
The FDA will hold an advisory panel meeting on Oct. 29 to review Makena, which has fueled speculation that the drug may actually be withdrawn, according to STAT.
However, an analyst from investment bank SVB Leerink surveyed 50 obstetricians and gynecologists about Makena and 86 percent said that, despite the failed study, they would still prescribe the drug.
Read the full article here.
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