Makena Might Stay On Market Despite Failed Confirmatory Trial In Pre-Term Birth
Subgroup analyses by AMAG may support ongoing use, but the once-controversial Makena seems unlikely to be pulled from the US market in any event since compounded progesterone is the only alternative therapy.
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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.
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.
Purchase of Cord Blood Registry is expected to boost commercialization of preterm birth drug Makena, while adding a stable growth business to AMAG and offering cost synergies.