AMAG’s Explanation For Makena's Failed Confirmatory Trial Faces Skeptical US FDA
Post hoc analyses show no convincing evidence that PROLONG trial's failure to meet its coprimary efficacy endpoints stemmed from baseline risk differences in subjects compared to an earlier trial, agency says; advisory committee is being asked whether to withdraw accelerated approval or keep the drug on the market, with or without a new confirmatory study.
You may also be interested in...
Clinicians and patients would look for 17P wherever they could find it if AMAG’s FDA-approved formulation of the preterm birth drug comes off the market, panelists said; Cowen analysts believe the potential for safety concerns posed by compounded formulations will save Makena from the regulatory chopping block.
CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.