Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Makena Might Stay On Market Despite Failed Confirmatory Trial In Pre-Term Birth

Executive Summary

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.

You may also be interested in...



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.

Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October

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.

AMAG Spends $700 Million To Better Sell Makena

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.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS124893

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel